The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal; Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal, Transvaginal, Intraoperative, Intraoperative Neurological.
Mode of Operation: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, Other [Notes].

Device Description

The Voluson E6/E8/E8Expert/E10 system is a full-featured Track 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.

AI/ML Overview

The provided 510(k) Premarket Notification Submission for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System states that clinical studies were not required to support substantial equivalence (page 2).

Therefore, there is no information in this document regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, training set size, or how ground truth for the training set was established.

The substantial equivalence determination was based on non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety) and compliance with applicable medical device safety standards (page 1). The device was found to conform with the following voluntary standards:

IEC60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety
IEC60601-1-2, Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
ISO14971, Application of risk management to medical devices
NEMA, Digital Imaging and Communications in Medicine (DICOM) Set (Radiology)

Additionally, the development process included quality assurance measures such as Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final Acceptance Testing (Validation), Performance testing (Verification), and Safety testing (Verification). Transducer materials and other patient contact materials were also evaluated for biocompatibility.

The acceptance criteria for the device are therefore implicit to its compliance with these non-clinical standards and internal quality assurance measures, as no separate clinical performance metrics are provided.

Summary

{0}------------------------------------------------

122327

SEP 2 1 2012

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a textured or patterned design.

":"","

510(k) Premarket Notification Submission

510(k) Summary

く

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	July 31, 2012
Submitter:	GE Healthcare [GE Healthcare Austria GmbH & Co OG]Tiefenbach 15Zipf, Austria 4871
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275
Secondary Contact Person:	Roland KuntscherRegulatory Affairs SpecialistGE Healthcare Austria GmbH & Co OGT:(++43)7682-3800-660F:(++43)7682 3800-47
Device: Trade Name:	Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System
Common/Usual Name:	Voluson E6/E8/E8Expert/E10
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K113758 Voluson E6/E8/E8Expert/E10 Diagnostic UltrasoundSystemK111582 LOGIQ S8 Diagnostic Ultrasound System
Device Description:	The Voluson E6/E8/E8Expert/E10 system is a full-featured Track3 ultrasound system, primarily for general radiology use andspecialized for OB/GYN with particular features for realtime3D/4D acquisition. It consists of a mobile console with keyboardcontrol panel; color LCD/TFT touch panel, color video displayand optional image storage and printing devices. It provides highperformance ultrasound imaging and analysis and hascomprehensive networking and DICOM capability. It utilizes avariety of linear, curved linear, matrix phased array transducersincluding mechanical and electronic scanning transducers, whichprovide highly accurate realtime three dimensional imagingsupporting all standard acquisition modes.
Intended Use:	The device is a general purpose ultrasound system. Specificclinical applications remain the same as previously cleared:

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is stylized and recognizable as the brand identity of GE.

Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal; Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).

The Voluson E6/E8/E8Expert/E10 employs the same Technology: fundamental scientific technology as its predicate devices.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

ﻬﺎ ﻓﻬ

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson E6/E8/E8Expert/E10 and its applications comply with voluntary standards:

1. IEC60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety
1. IEC60601-1-2,Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
1. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
1. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
1. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
NEMA UD 2, Acoustic Output Measurement Standard 6. for Diagnostic Ultrasound Equipment
1. ISO14971. Application of risk management to medical devices
1. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology) ·

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Image /page/2/Picture/0 description: The image shows a logo of General Electric (GE). The logo is a circular emblem with the letters 'GE' intertwined in a stylized, cursive font. The letters are surrounded by a decorative, swirling pattern within the circle.

The following quality assurance measures were applied to the development of the system:

Risk Analysis .
. Requirements Reviews
Design Reviews ●
Testing on unit level (Module verification) .
. Integration testing (System verification)
Final Acceptance Testing (Validation) ●
Performance testing (Verification) .
Safety testing (Verification) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Voluson E6/E8/E8/ Expert/E10, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Voluson E6/E8/E8 Expert/E10 to be Conclusion: as safe, as effective, and performance is substantially equivalent to the predicate device(s).

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" surrounding the top and left side of the circle. The text is written in a sans-serif font and is arranged to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP 2 1 2012

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K122327

Trade/Device Name: Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 28, 2012 Received: August 29, 2012

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System, as described in your premarket notification:

	Transducer Model Number
RAB2-5-DRAB4-8-DRIC5-9-DRNA5-9-DRRE6-10-DAB2-7-D4C-DIC5-9-DPA6-8-DSP10-16-D	RSP6-16-DRIC6-12-DRAM3-8RSM5-149L-D3S-DP2DP6DM6C11L-D	C1-5-DML6-15-DRM6CRRE5-10-DRM14L3Sp-DC4-8-DRAB6-DeM6CS4-10-D

{4}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be If your device is classified (see above) into emiss affecting your device can be found in the subject to such additions. Title 21, Parts 800 to 895. In addition, FDA may publish further
Code of Federal Regulations, Title 21, Parts 800 to Beats Code of I ederal Regaration your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Agt or any Please be advised that FDA's Issualice of a substance requirements of the Act or any
FDA has made a determination that your device complies. You must compley with all FDA has made a determination mat your device compless . You must comply with all the Federal statutes and regulations administered by oner edenar and listing (21 CFR Part 807); abeling (21
Act's requirements, including, but not limited to: registres in the ev Act's requirements, including, but not minical to: requirements as set forth in the quality systems (QS)
CFR Part 801); good manufacturing practice requirements as see forth CFR Part 801); good manufacturing practice requirements as seconduct radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic provisions i (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket netification.
In the subscription of the first of any device to a logally market pred This letter will allow you to begin marketing your device to a legally marketed predicate device results
The FDA finding of substantial equivalence of your device to areased The FDA Tinding of Substantal Cquivalence or your device to proceed to market.
in a classification for your device and thus permits your device to proceed to market.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to If you desire specific advice for your device on our areasones and 15809.htm for the Center for
http://www.fda.gov/AboutFDA/CenterSDffices/CDRHOPfices/crom I 15809.html or r http://www.tda.gov/AboutFDA/CemersOffices/Office of Compliance. Also, please note the regulations Devices and Kadiological Health S (ODNI S) Online the Corner (2) CFF Part 807.97). For questions
entitled, "Misbranding by reference to premarket notifical CCFR Part 803), p entitled, "Misbranding by reference to premaince (1) C CFR Part 803), please go to
regarding the reporting of adverse events under the MDR regulation (2) CFR Part of regarding the reporting of adverse evens ander the healthuit.htm for the CDRH's Office of Illtp://www.lua.go/iometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours,

Marshall D. O'Hara, for.

Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known):

Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Device Name:

Indications for Use:

The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

Prescription Use_X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K122327

{6}------------------------------------------------

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Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E6/E8/E8Expert/E10 system and for all of its probe/mode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified Voluson E6/E8ExpervE10. In a similar manner, "E'' represents combinations added to the unmodified Voluson E6/E8/E8Expert/E10 via Guidance Appendix E. This modification did not alter the previously cleared system level indications or clinical applications.

(Division Sign-Off)
Division of Radiological Devices
510k K122337
DIVD

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white and has a vintage look.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	Color#Doppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics(7)	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Abdominal(1)	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Other
Exam Type. Means of Access
Transesophageal
Transrectal[8]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: {1} Abdominal includes renal, GYN/Pelvic.

[1] Addonillial inolaoo renal, o Press, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients [3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[5] Elastography Intagrity - Listion)
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] 4D color Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Aluhul DOTK
(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
K122389

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white, with the letters and the surrounding circle appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RAB2-5-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other
Exam Type. Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division Sign-Off)
Division of Radiological Devices
K1aa337

-3 0

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RAB4-8-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation								Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes		HarmonicImaging	CodedPulse
Ophthalmic									P	P	[5,6]
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

Laparoscopic

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[0] Includes infertility monitoring of follicle development
[7] Includes infertility monitoring of follicle development

[1] Includes intertility monitoring of Ibincie development
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/ColorPWD or CWD, B/B/E/R/S/F/

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Slan of Radiolo 210k

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The logo is in black and white.

GE Healthcare

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RIC5-9-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse	Other (Notes)
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5,6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[5,6,9]
Transvaginal	P	P	P		P	P	P	P	P	P	[5,6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[9] Elastography Imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological

Ivision of Radiological Devices 510k

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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined in a stylized, circular design. The logo is black and white and has a vintage look.

GE Healthcare

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RNA5-9-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6]
Small Organ [2]	P	P	P	P	P	P	P	P	P	P	[5,6]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	[5]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other
Exam Type. Means of Access
Transesophageal
Transrectal [8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal is Neonatal and pediatric Notes:

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediativ and neonatal patients

[3] Cardiac is Neonatal and Pediatric.

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-off)

510

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Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RRE6-10-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[3]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type. Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[5,6]
Transvaginal	P	P	P		P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[5] 3D/4D Imaging Mode Notes:

[6] Includes imaging of guidance of biopsy (3D/4D)

[8] Includes urology/prostate

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-510k

{13}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with AB2-7-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic								P	P	P	[6]
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[6]
Pediatric	P	P	P		P	P	P	P	P	P	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular										P
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
I anarosconic .

Laparoscopic .
N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[7] Includes intertlify monitoring of tothere development
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)


(Division Sign-Off)
Division of Radiological Devices
510k

f Radiological Devices
510k [K122337](https://510k.innolitics.com/search/K122337)

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white.

#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson E6/E8/E8Expert/E10 with 4C-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|-----|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |     |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Fetal / Obstetrics[7]                              | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              | [6]              |     |
| Abdominal[1]                                       | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              | [6]              |     |
| Pediatric                                          |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Peripheral Vascular                                | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              | P                | [6] |
| Musculo-skeletal Conventional                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |     |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
510K [K122337](https://510k.innolitics.com/search/K122337)

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular frame. The logo is in black and white and has a vintage look.

# GE Healthcare

510(k) Premarket Notification Submission

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with IC5-9-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                             |                |                  |  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-----------------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined Harmonic<br>Modes* | Coded<br>Pulse | Other<br>[Notes] |  |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Fetal / Obstetrics[7]                              | P                 | P | P             |               | P                | P                  | P                | P                           | P              | [6,9]            |  |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Pediatric                                          |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Peripheral Vascular                                |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Musculo-skeletal Conventional                      |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Other                                              |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Transrectal[8]                                     | P                 | P | P             |               | P                | P                  | P                | P                           | P              | [6,]             |  |
| Transvaginal                                       | P                 | P | P             |               | P                | P                  | P                | P                           |                | [6,]             |  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                             |                |                  |  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                             |                |                  |  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[6] Includes imaging of guidance of biopsy (2D) Notes:

[0] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[9] Elastography Imaging- Elasticity

[9] Elastography Imaging- Elashcity
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[*] Combined modes are B/M, B/Color M, B/PWD or WE, (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
510k [K122327](https://510k.innolitics.com/search/K122327)

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white, with the letters and the outer circle appearing in black against a white background.

# Diagnostic Ultrasound Indications for Use Form

#### GE Voluson E6/E8/E8Expert/E10 with PA6-8-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                           | Mode of Operation |   |            |            |               |                 |               |                |                  |             |               |  |
|-----------------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|----------------|------------------|-------------|---------------|--|
| Clinical Application<br><i>Anatomy/Region of Interest</i> | B                 | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other [Notes] |  |
| Ophthalmic                                                |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Fetal / Obstetrics[7]                                     |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Abdominal[1]                                              | P                 | P | P          | P          | P             | P               | P             | P              | P                | P           |               |  |
| Pediatric                                                 | P                 | P | P          | P          | P             | P               | P             | P              | P                | P           |               |  |
| Small Organ[3]                                            |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Neonatal Cephalic                                         | P                 | P | P          | P          | P             | P               | P             | P              | P                | P           | P             |  |
| Adult Cephalic                                            |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Cardiac[3]                                                | P                 | P | P          | P          | P             | P               | P             | P              | P                | P           | P             |  |
| Peripheral Vascular                                       |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Musculo-skeletal Conventional                             |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Musculo-skeletal Superficial                              |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Other[4]                                                  |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Exam Type, Means of Access                                |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Transesophageal                                           |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Transrectal[8]                                            |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Transvaginal                                              |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Transuretheral                                            |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Intraoperative                                            |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Intraoperative Neurological                               |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Intravascular                                             |                   |   |            |            |               |                 |               |                |                  |             |               |  |
| Laparoscopic                                              |                   |   |            |            |               |                 |               |                |                  |             |               |  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal is Neonatal , pediatric and obstetrics Noles:

[3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
510k [K122327](https://510k.innolitics.com/search/K122327)

{17}------------------------------------------------

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with SP10-16-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                    |                     |                |                 |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-----------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Note] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Fetal / Obstetrics[7]                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Pediatric                                          | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6]             |
| Small Organ[2]                                     | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              |                 |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Peripheral Vascular                                | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6]             |
| Musculo-skeletal Conventional                      |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Musculo-skeletal Superficial                       | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6]             |
| Other                                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Exam Type, Means of Access                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transrectal[8]                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Indication; P = previously cleared by FDA, E = adical under rippinant = "
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonat Notes:

[6] Includes imaging of guidance of biopsy (2D)

[6] Includes imaging of guidance of blopsy (2D)
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

*(Division Sign-Off)*
Division of Radiological Devices
510k [K122327](https://510k.innolitics.com/search/K122327)

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, contrasting with the white background.

510(k) Premarket Notification Submission

#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson E6/E8/E8Expert/E10 with RSP6-16-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                    |                     |                |                  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Fetal / Obstetrics(7)                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Pediatric                                          | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Small Organ[2]                                     | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Peripheral Vascular                                | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Musculo-skeletal Conventional                      | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Musculo-skeletal Superficial                       | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Other                                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transrectal[8]                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Intraoperative                                     | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              |                  |
| Intraoperative Neurological                        | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              |                  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D) ·

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division of Radiological Devices
510k [K122337](https://510k.innolitics.com/search/K122337)

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows a logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white and appears to be a vintage or older version of the GE logo.

.

#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RIC6-12-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Fetal / Obstetrics[7]                              | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Pediatric                                          |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Peripheral Vascular                                |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Conventional                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal[8]                                     | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Transvaginal                                       | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
510k [K122327](https://510k.innolitics.com/search/K122327)

{20}------------------------------------------------

Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The logo is in black and white and has a vintage look.

510(k) Premarket Notification Submission

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RAM3-8 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                   | Mode of Operation |   |               |               |                  |                    |                  |                    |                     |                |                 |
|-----------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-----------------|
| Clinical Application              | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Note] |
| <i>Anatomy/Region of Interest</i> |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Ophthalmic                        |                   |   |               |               |                  |                    |                  |                    |                     |                | [5,6]           |
| Fetal / Obstetrics[7]             | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,6]           |
| Abdominal[1]                      | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,6]           |
| Pediatric                         | P                 | P | P             |               | P                | P                  | P                | P                  | P                   |                |                 |
| Small Organ[2]                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Neonatal Cephalic                 |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Adult Cephalic                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Cardiac[3]                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Peripheral Vascular               |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Musculo-skeletal Conventional     | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [5,             |
| Musculo-skeletal Superficial      |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Other                             |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Exam Type. Means of Access        |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transesophageal                   |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transrectal                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transvaginal                      |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transuretheral                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intraoperative                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intraoperative Neurological       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intravascular                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |

Laparoscopic
N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[0] Includes infertility monitoring of follicle development

[1] Includes infertility monitoring of follicie development
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{21}------------------------------------------------

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## Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RSM5-14 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Fetal / Obstetrics[7]                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Pediatric                                          | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Small Organ[2]                                     | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Peripheral Vascular                                | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Musculo-skeletal Conventional                      | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Musculo-skeletal Superficial                       | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Exam Type, Means of Access                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{22}------------------------------------------------

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# GE Healthcare

510(k) Premarket Notification Submission

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with 9L-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                    |                     |                |                 |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-----------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Note] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Fetal / Obstetrics[7]                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Pediatric                                          | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [6]             |
| Small Organ[2]                                     | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [6]             |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Peripheral Vascular                                | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [6]             |
| Musculo-skeletal Conventional                      | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [6]             |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Other                                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                 |

Laparocopic
N = new indication; P = previously cleared by FDA; E = added under Appendix E

indication, P = previously cleared by FDA, £ = adoct and rispenses = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Notes:

[6] Includes imaging of guidance of biopsy (2D)

[6] Includes imaging of guidance of blopsy (2D)
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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510k [K122379](https://510k.innolitics.com/search/K122379)

{23}------------------------------------------------

Image /page/23/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a stylized circular frame. The letters and the frame are in black, contrasting with the white background. The logo has a vintage or classic appearance due to its design and the slightly distressed texture.

#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with 3S-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                          | Mode of Operation |   |               |               |                  |                       |                  |                    |                     |                |                  |
|----------------------------------------------------------|-------------------|---|---------------|---------------|------------------|-----------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical<br>Application<br>Anatomy/Region<br>of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color<br>M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Ophthalmic                                               |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Fetal /                                                  | P                 | P | P             | P             | P                | P                     | P                | P                  | P                   | P              |                  |
| Abdominal[1]                                             | P                 | P | P             | P             | P                | P                     | P                | P                  | P                   | P              |                  |
| Pediatric                                                | P                 | P | P             | P             | P                | P                     | P                | P                  | P                   | P              |                  |
| Small Organ[2]                                           |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Neonatal                                                 |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Adult Cephalic                                           | P                 | P | P             | P             | P                | P                     | P                | P                  | P                   | P              |                  |
| Cardiac[3]                                               | P                 | P | P             | P             | P                | P                     | P                | P                  | P                   | P              |                  |
| Peripheral                                               |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Musculo-skeletal                                         |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Musculo-skeletal                                         |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Other                                                    |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Exam Type.                                               |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Transesophageal                                          |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Transrectal                                              |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Transvaginal                                             |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Transuretheral                                           |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Intraoperative                                           |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Intraoperative                                           |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Intravascular                                            |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |
| Laparoscopic                                             |                   |   |               |               |                  |                       |                  |                    |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic Notes:

[3] Cardiac is adult and Pediatric

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{24}------------------------------------------------

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510(k) Premarket Notification Submission

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with P2D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
|                                                    | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Fetal / Obstetrics[7]                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Pediatric                                          |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Adult Cephalic                                     |                   |   |               | P             |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                                         |                   |   |               | P             |                  |                    |                  |                   |                     |                |                  |
| Peripheral Vascular                                |                   |   |               | P             |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Conventional                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[3] Cardiac is adult and Pediatric Notes:

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{25}------------------------------------------------

Image /page/25/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, creating a high-contrast design.

# Diagnostic Ultrasound Indications for Use Form

# GE Voluson E6/E8/E8Expert/E10 with P6D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic                                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Fetal / Obstetrics[7]                              |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Abdominal[1]                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Pediatric                                          |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Small Organ[2]                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Neonatal Cephalic                                  |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Adult Cephalic                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                                         |   |   |               | P             |                  |                    |                  |                   |                     |                |                  |
| Peripheral Vascular                                |   |   |               | P             |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Conventional                      |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Superficial                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Other                                              |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Exam Type. Means of Access                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal                                    |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal                                        |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transvaginal                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transuretheral                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological                        |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                                      |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E [3] Cardiac is adult and Pediatric

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Notes:

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{26}------------------------------------------------

Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.

#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with M6C Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                               | Mode of Operation |   |         |         |         |         |         |          |          |       |         |  |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|---------|--|
| Clinical Application          | B                 | M | PW      | CW      | Color   | Color M | Power   | Combined | Harmonic | Coded | Other   |  |
| Anatomy/Region of Interest    |                   |   | Doppler | Doppler | Doppler | Doppler | Doppler | Modes    | Imaging  | Pulse | [Notes) |  |
| Ophthalmic                    |                   |   |         |         |         |         |         |          |          |       |         |  |
| Fetal / Obstetrics [7]        | P                 | P | P       | P       | P       | P       | P       | P        | b        | b     | [୧]     |  |
| Abdominal[1]                  | P                 | P | P       | P       | P       | P       | P       | P .      | P        | P     | (6)     |  |
| Pediatric                     | b                 | P | P       | P       | P       | P       | P       | P        | P        | P     | [e]     |  |
| Small Organ(2)                |                   |   |         |         |         |         |         |          |          |       |         |  |
| Neonatal Cephalic             |                   |   |         |         |         |         |         |          |          |       |         |  |
| Adult Cephalic                |                   |   |         |         |         |         |         |          |          |       |         |  |
| Cardiac(3)                    |                   |   |         |         |         |         |         |          |          |       |         |  |
| Peripheral Vascular           |                   |   |         |         |         |         |         |          |          |       |         |  |
| Musculo-skeletal Conventional |                   |   |         |         |         |         |         |          |          |       |         |  |
| Musculo-skeletal Superficial  |                   |   |         |         |         |         |         |          |          |       |         |  |
| Other                         |                   |   |         |         |         |         |         |          |          |       |         |  |
| Exam Type, Means of Access    |                   |   |         |         |         |         |         |          |          |       |         |  |
| Transesophageal               |                   |   |         |         |         |         |         |          |          |       |         |  |
| Transrectal                   |                   |   |         |         |         |         |         |          |          |       |         |  |
| Transvaginal                  |                   |   |         |         |         |         |         |          |          |       |         |  |
| Transuretheral                |                   |   |         |         |         |         |         |          |          |       |         |  |
| Intraoperative                |                   |   |         |         |         |         |         |          |          |       |         |  |
| Intraoperative Neurological   |                   |   |         |         |         |         |         |          |          |       |         |  |
| Intravascular                 |                   |   |         |         |         |         |         |          |          |       |         |  |
| Laparoscopic                  |                   |   |         |         |         |         |         |          |          |       |         |  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Division of Radiological Devices
510k K1220140

37

{27}------------------------------------------------

Image /page/27/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white and has a vintage look.

#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with 11L-D Transducer

Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                    |                     |                |                  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Fetal / Obstetrics[7]                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Pediatric                                          | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6,9]            |
| Small Organ[2]                                     | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6,9]            |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Peripheral Vascular                                | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6,9]            |
| Musculo-skeletal Conventional                      | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6,9]            |
| Musculo-skeletal Superficial                       | P                 | P | P             |               | P                | P                  | P                | P                  | P                   | P              | [6,9]            |
| Other                                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Exam Type, Means of Access                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[6] Includes imaging of guidance of biopsy (2D)

[9] Elastography Imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with C1-5-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                | [6]              |
| Fetal / Obstetrics[7]                              | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              | [6]              |
| Abdominal[1]                                       | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              | [6]              |
| Pediatric                                          |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Peripheral Vascular                                | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              | [6]              |
| Musculo-skeletal Conventional                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| <i>Exam Type. Means of Access</i>                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[ / ] Includes internity unomoting of Ibinets covery in the more of Color/PWD or CWD, B/Power/PWD.

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{29}------------------------------------------------

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# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with ML6-15-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic                                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Fetal / Obstetrics[7]                              |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Abdominal[1]                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Pediatric                                          | P | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [6,9]            |
| Small Organ[2]                                     | P | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [6,9]            |
| Neonatal Cephalic                                  |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Adult Cephalic                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Peripheral Vascular                                | P | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [6,9]            |
| Musculo-skeletal Conventional                      | P | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [6,9]            |
| Musculo-skeletal Superficial                       | P | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [6,9]            |
| Other                                              |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Exam Type, Means of Access                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal                                    |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal                                        |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transvaginal                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transuretheral                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological                        |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                                      |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[6] Includes imaging of guidance of biopsy (2D)

[9] Elastography Imaging-Elasticity

[1] Elastography Integring Elasher!)
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{30}------------------------------------------------

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RM6C Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
|                                                    | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |  |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Fetal / Obstetrics[7]                              | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Abdominal[1]                                       | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Pediatric                                          | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Peripheral Vascular                                |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Musculo-skeletal Conventional                      | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Exam Type, Means of Access                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[ 1] Meduces Informity momenting only B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{31}------------------------------------------------

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## Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RRE5-10-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic                                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Fetal / Obstetrics[7]                              |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Abdominal[1]                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Pediatric                                          |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Small Organ[2]                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Neonatal Cephalic                                  |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Adult Cephalic                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Peripheral Vascular                                |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Conventional                      |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Superficial                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Other                                              |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Exam Type, Means of Access                         |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal                                    |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal[8]                                     | P | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [ 5,6,9]         |
| Transvaginal                                       | P | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [ 5,6,9]         |
| Transuretheral                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                                     |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological                        |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                                      |   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                                       |   |   |               |               |                  |                    |                  |                   |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[5] 3D/4D Imaging Mode Notes:

[6] Includes imaging of guidance of biopsy (3D/4D)

[8] Includes urology/prostate

[9] Elastography Imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{32}------------------------------------------------

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# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RM14L Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |  |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Fetal / Obstetrics[7]                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Abdominal[1]                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Pediatric                                          | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Small Organ[2]                                     | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Peripheral Vascular                                | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Musculo-skeletal Conventional                      | P                 | P | P.            |               | P                | P                  | P                | P                 | P                   | P              | .[5,6]           |  |
| Musculo-skeletal Superficial                       | P                 | P | P             |               | P                | P                  | P                | P                 | P                   | P              | [5,6]            |  |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[*] melludes minging or garage or garant, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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43

{33}------------------------------------------------

Image /page/33/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white and has a vintage look.

#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with 3Sp-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |  |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Fetal / Obstetrics[7]                              | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              |                  |  |
| Abdominal[1]                                       | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              |                  |  |
| Pediatric                                          | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              |                  |  |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Adult Cephalic                                     | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              |                  |  |
| Cardiac[3]                                         | P                 | P | P             | P             | P                | P                  | P                | P                 | P                   | P              |                  |  |
| Peripheral Vascular                                |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Musculo-skeletal Conventional                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Other                                              |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Exam Type, Means of Access                         |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[I] Abdominal includes renal, GYN/Pelvic Notes:

[3] Cardiac is adult and Pediatric

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{34}------------------------------------------------

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with C4-8-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                               | Mode of Operation |   |         |         |         |         |         |       |                   |       |         |  |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|-------|-------------------|-------|---------|--|
| Clinical Application          | B                 | M | PW      | CW      | Color   | Color M | Power   |       | Combined Harmonic | Coded | Other   |  |
| Anatomy/Region of Interest    |                   |   | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging           | Pulse | [Notes) |  |
| Ophthalmic                    |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Fetal / Obstetrics [7]        | P                 | P | P       | P       | P       | P       | P       | P     | P                 | P     | [ર]     |  |
| Abdominal[l]                  | P                 | P | P       | P       | P       | P       | P       | P     | P                 | P     | [e]     |  |
| Pediatric                     | P                 | P | P -     | P       | P       | P       | P       | P     | P                 | P     | [6]     |  |
| Small Organ(2)                |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Neonatal Cephalic             |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Adult Cephalic                |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Cardiaclii                    |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Peripheral Vascular           | P                 | P | P       | P       | P       | P       | P       | P     | P                 | P     | (6)     |  |
| Musculo-skeletal Conventional |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Musculo-skeletal Superficial  |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Other                         |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Exam Type, Means of Access    |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Transesophageal               |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Transrectal                   |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Transvaginal                  |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Transuretheral                |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Intraoperative                |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Intraoperative Neurological   |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Intravascular                 |                   |   |         |         |         |         |         |       |                   |       |         |  |
| Laparoscopic                  |                   |   |         |         |         |         |         |       |                   |       |         |  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[ / ] includes interimy inomoning of tomers covery.incent
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{35}------------------------------------------------

Image /page/35/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The logo is presented in black against a white background, creating a high-contrast visual. The design is simple yet recognizable, representing the brand identity of General Electric. The logo is a classic example of corporate branding.

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RAB6-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                                                    | Mode of Operation |   |               |               |                  |                    |                  |                    |                     |                |                  |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Ophthalmic                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Fetal / Obstetrics[7]                              | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Abdominal[1]                                       | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Pediatric                                          | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Small Organ[2]                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Neonatal Cephalic                                  |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Adult Cephalic                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Cardiac[3]                                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Peripheral Vascular                                |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Musculo-skeletal Conventional                      | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   | P              | [5,6]            |
| Musculo-skeletal Superficial                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Other                                              |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Exam Type. Means of Access                         |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transesophageal                                    |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transrectal                                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transvaginal                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Transuretheral                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Intraoperative                                     |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Intraoperative Neurological                        |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Intravascular                                      |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |
| Laparoscopic                                       |                   |   |               |               |                  |                    |                  |                    |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[ *] Librauds Micrimy Licean M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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{36}------------------------------------------------

Image /page/36/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in black, while the background is white. The logo has a vintage or classic appearance.

#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with eM6C Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                               | Mode of Operation |   |               |               |                   |                    |                  |                    |                     |                |                  |
|-------------------------------|-------------------|---|---------------|---------------|-------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application          | B                 | M | PW<br>Doppler | CW<br>Doppler | Color*<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Anatomy/Region of Interest    |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Ophthalmic                    |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Fetal / Obstetrics[7]         | P                 | P | P             |               | P                 | P                  | P                | P                  | P                   | P              | [5,6]            |
| Abdominal[1]                  | P                 | P | P             |               | P                 | P                  | P                | P                  | P                   | P              | [5,6]            |
| Pediatric                     | P                 | P | P             |               | P                 | P                  | P                | P                  | P                   | P              | [5,6]            |
| Small Organ[2]                |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Neonatal Cephalic             |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Adult Cephalic                |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Cardiac[3]                    |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Peripheral Vascular           |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Musculo-skeletal Conventional | P                 | P | P             |               | P                 | P                  | P                | P                  | P                   | P              | [5,6]            |
| Musculo-skeletal Superficial  |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Other                         |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Exam Type. Means of Access    |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Transesophageal               |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Transrectal                   |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Transvaginal                  |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Transuretheral                |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Intraoperative                |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Intraoperative Neurological   |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Intravascular                 |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |
| Laparoscopic                  |                   |   |               |               |                   |                    |                  |                    |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[9 4D color Doppler

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510k [K122337](https://510k.innolitics.com/search/K122337)

{37}------------------------------------------------

Image /page/37/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, intertwined font. The logo appears to be a vintage or classic design, possibly representing the General Electric company.

# Diagnostic Ultrasound Indications for Use Form

#### GE Voluson E6/E8/E8Expert/E10 with S4-10-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

|                               | Mode of Operation |   |               |               |                  |                    |                  |                   |                     |                |                  |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application          | B                 | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Anatomy/Region of Interest    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Ophthalmic                    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Fetal / Obstetrics[7]         | E                 | E | E             | E             | E                | E                  | E                | E                 | E                   | E              |                  |
| Abdominal[1]                  | E                 | E | E             | E             | E                | E                  | E                | E                 | E                   | E              |                  |
| Pediatric                     | E                 | E | E             | E             | E                | E                  | E                | E                 | E                   | E              |                  |
| Small Organ[2]                | E                 | E | E             | E             | E                | E                  | E                | E                 | E                   | E              |                  |
| Neonatal Cephalic             | E                 | E | E             | E             | E                | E                  | E                | E                 | E                   | E              |                  |
| Adult Cephalic                |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Cardiac[3]                    | E                 | E | E             | E             | E                | E                  | E                | E                 | E                   | E              |                  |
| Peripheral Vascular           |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Conventional |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Musculo-skeletal Superficial  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Other[4]                      |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Exam Type, Means of Access    |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transesophageal               |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transrectal[8]                |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transvaginal                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Transuretheral                |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative                |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intraoperative Neurological   |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Intravascular                 |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |
| Laparoscopic                  |                   |   |               |               |                  |                    |                  |                   |                     |                |                  |

N = new indication; P = previously cleared by FDA; E = added under Appendix E (Previously cleared on LOGIQ S8 [K111582](https://510k.innolitics.com/search/K111582)) Notes:

[1] Abdominal includes renal, GYN/Pelvic, Urology

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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510k

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.