The Voluson E-Series 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 document is a 510(k) Premarket Notification Submission for the GE Voluson E-Series diagnostic ultrasound systems. It focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a performance study against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, study design parameters, and outcomes is not present in this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of acceptance criteria and reported device performance in the context of a new clinical study. Instead, it asserts substantial equivalence to predicate devices based on:

The device being a general-purpose ultrasound system with clinical applications remaining the same as previously cleared.
Minor hardware (new Power Supply, new Beamformer, new ECG-Module) and software (features like STIC, HDLive, SonoRenderstart, Cine Loop) improvements.
The system employing the same fundamental scientific technology as its predicate devices.
Conformity with applicable medical device safety standards.

2. Sample Size Used for the Test Set and Data Provenance:

No test set sample size or data provenience (country of origin, retrospective/prospective) is mentioned in this document for a clinical performance study. The submission explicitly states: "The subject of this premarket submission, Voluson E Series, did not require clinical studies to support substantial equivalence."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

No information regarding experts used to establish ground truth or their qualifications is provided, as no clinical studies were performed.

4. Adjudication Method:

No adjudication method is mentioned, as no clinical studies were conducted to establish new ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done, nor is there any mention of human readers improving with or without AI assistance. This device is an ultrasound system, not an AI diagnostic tool in the sense of the query.

6. Standalone Performance Study:

No standalone (algorithm-only) performance study was conducted or reported.

7. Type of Ground Truth Used:

No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for a clinical performance study since none was required. The "ground truth" for this submission is implicitly the established performance and safety of its predicate devices and compliance with recognized standards.

8. Sample Size for the Training Set:

No training set sample size is indicated, as this submission is not about an AI/ML algorithm requiring a training set in the typical sense for a new clinical claim.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as no training set, in the context of a new AI/ML algorithm, was described.

Summary of Device and Evidence Presented:

The GE Voluson E-Series (including models E6/E8/E8Expert/E8Expert Limited Edition/E10) is a diagnostic ultrasound system intended for general radiology use, particularly specialized for OB/GYN with features for real-time 3D/4D acquisition.

The submission focuses on modifications to a previously cleared device (K122327 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System) and predicate device (K120741 Voluson S6/S8 Diagnostic Ultrasound System). The modifications include a new power supply, new beamformer, and new ECG-module, along with minor software improvements to existing features (STIC, HDLive, SonoRenderstart, Cine Loop).

The argument for substantial equivalence is based on:

The intended use and clinical applications remaining the same as previously cleared.
The fundamental scientific technology remaining the same.
Non-clinical testing demonstrating conformity with safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety) and voluntary standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, DICOM).
Quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
The assertion that clinical studies were not required to support substantial equivalence.

In essence, this 510(k) submission is a declaration that the modified device is as safe and effective as its legally marketed predicate devices, and therefore does not require new or updated clinical performance data.

Summary

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

JUN 1 9 2013

K131267
Page 1 of 3

510(k) Premarket Notification Submission

510(k) Summary

: 上

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	May 2, 2013
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:	Voluson E SeriesTrade Name:
	Models: Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10 Diagnostic Ultrasound Systems
Common/Usual Name:	Voluson E6/E8/E8Expert/E8Expert Limited Edition/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):	K122327 Voluson E6/E8/E8Expert/E10 Diagnostic UltrasoundSystem
	K120741 Voluson S6/S8 Diagnostic Ultrasound System
Device Description:	The Voluson E-Series system is a full-featured Track 3ultrasound 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.

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the inner part of the circle are black, while the outer ring of the circle is white.

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

Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The logo is in black and white, with the letters and the outline of the circle appearing in black against a white background.

GE Healthcare

510(k) Premarket Notification Submission

The device is a general purpose ultrasound system. Specific Intended Use: 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; Peripheral Vascular; Transvaginal; Transrectal Voluson E-Series will provide new Power Supply (Wide Range), Device Modification: new Beamformer (Integrated circuit) and new ECG-Module (Hardware option) from the Voluson S6/S8 (K120741). There have also been minor software improvements to a few existing software features e STIC (Spatial Temporal Image Correlation), HDLive (HD Live II), SonoRenderstart (SonoRendersstart II) and Cine Loop (Start/Length). The Voluson E-Series employs the same fundamental scientific Technology: technology as its predicate devices.

Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

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 E-Series and its applications comply with voluntary standards:

1. 1. AAMI/ANSI ES60601-1. 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

{2}------------------------------------------------

Image /page/2/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.

Devices- Part 1: Evaluation and Testing- Third Edition

1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
1. ISO14971, Application of risk management to medical devices
1. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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 E Series, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Voluson E Series to be as safe, as Conclusion: 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 & Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2013

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

Re: K131267

Trade/Device Name: Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 31, 2013 Received: June 3, 2013

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. .. Please.note: .. CDRH. does.not.evaluate.information.related.to.contract.liability, warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10, as described in your premarket notification:

	Transducer Model Number
RAB2-5-D	9L-D	RRE5-10-D
RIC5-9-D	P2D	RM14L
RNA5-9-D	P6D	3Sp-D
4C-D	11L-D	C4-8-D
IC5-9-D	C1-5-D	RAB6-D
RSP6-16-D	ML6-15-D	eM6C
RIC6-12-D	RM6C	S4-10-D

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

Page 2-- Mr. Behn

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

—Sincerely-yours,—

Sm. 7)

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are solid black, contrasting with the white background.

510(k) Number (if known): K131267

Device Name: Voluson E-Series (Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10) Diagnostic Ultrasound Systems

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

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

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

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

-Concurrence of-GDRI-1,-Office of-In-Vitro-Diagnostics and-Radiological-Health-(OIR)-

Page 1 of 23

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

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E Series system and for all of its probe/mode combinations. Combinations identified as "P" represents those previously cleared with the unmodified Voluson E6/E8/E8Expert/E10 and "E" are those that have been added by Appendix E of the FDA Ultrasound guidance. This modification did not add to the previously cleared system level.or transducer indications or clinical applications.

Confidential and Privileged. This document contains confidential and priviteged trade scerets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Hectric Co. All rights reserved

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular border. The letters are stylized and connected, creating a unique and recognizable design. The logo is presented in black and white, with the letters and border appearing in black against a white background. The overall design is simple yet iconic, representing the well-known multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form GE Voluson E-Series (Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10)

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	[5,6,9]
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 Organ21	P	P	P	P	P	P	P	P	P	P	[5,6,9]
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
Cardiac[1]	P	P	P	P	P	P	P	P	P	P	[5]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6,9]
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
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

(2) Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients [3] Cardiac is Adult and Pediatric

[5] 3D/4D Imaging Mode.

f61 Includes imaging of quidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are BIM, 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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 2 of 23

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

Diagnostic Uitrasound Indications for Use Form

GE Voluson E Series 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	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics(7)	P	P	P	E	P	P	P	P	P	P	[5,6]
Abdominal11	P	P	P	E	P	P	P	P	P	P	[5,6]
Pediatric
Small Organ(2)
Neonatal Cephalic
Adult Cephalic
Cardiac11
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	E	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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 3 of 23

{9}------------------------------------------------

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.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series 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	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics[71]	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

|5| 3D/4D Imaging Mode Notes:

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

{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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 4 of 23

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

Image /page/10/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 E Series 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[1]	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

Notes: [1] Abdominal is Neonatal and pediatric

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric 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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 5 of 23

{11}------------------------------------------------

Image /page/11/Picture/15 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a circular design. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with 4C-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 / Obstetrics171	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal111	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric
Small Organ121
Neonatal Cephalic
Adult Cephalic
Cardiac131
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

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

[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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 6 of 23

{12}------------------------------------------------

Image /page/12/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 letters are stylized and connected in a cursive-like manner. The logo is black and white, with the letters and border appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with IC5-9-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[1]	P	P	P		P	P	P	P	P	P	[6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[1]
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	[6,9]
Transvaginal	P	P	P		P	P	P	P	P	P	[6,9]
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:

[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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 7 of 23

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

Image /page/13/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 are stylized with curved lines and loops, giving the logo a distinctive and recognizable appearance.

GE Healthcare

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with RSP6-16-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[1]
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
-Intraoperative-Neurological-
Intravascular
Laparoscopic

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

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

[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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 8 of 23

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

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is presented in black and white, with the letters and border appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson E Series 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	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 / Obstetrics171	P	P	P		P	P	P	P	P	P	( 5,6)
Abdomina]™
Pediatric
Small Organizi
Neonatal Cephalic
Adult Cephalic
Cardiac™
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectall&i	P	P	P		P	b	b	P	P	P	( 5,6)
Transvaginal	P	P	P		P	P	P	P	P	P	5.61
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)

[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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 9 of 23

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

Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with 9L-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 / Obstetrics171
Abdominal™
Pediatric	P	P	P	P	P	P	P	P	P	P	[୧]
Small Organ 21	P	P	P	P	P	P	P	P	P	b	( ୧)
Neonatal Cephalic
Adult Cephalic
Cardiacl31
Peripheral Vascular	P	P	P	P	la	b	P	P	P	P	(ર)
Musculo-skeletal Conventional	P	P	P	P	l>	P	P	P	P	P	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

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

[6] Includes imaging of guidance of biopsy (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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Notes:

Page 10 of 23

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with P2D 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 [1]
Abdominal [1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic				P
Cardiac [1]				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

Notes: {3} Cardiac is adult and Pediatric

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 11 of 23

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

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The letters and the border are black, while the background is white. The logo is a well-known symbol associated with the General Electric company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with P6D 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[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
Transurethera!
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

(Please oo not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 12 of 23

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

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, while the background is white.

GE Healthcare

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with 11L-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 / Obstetrics17
Abdominal11
Pediatric	P	P	P		P	P	P	P	P	P	[6,9]
Small Organ21	P	P	P		P	P	P	P	P	P	[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac11
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

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

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 13 of 23

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

Image /page/19/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 letters are stylized with curved lines and loops, creating a distinctive and recognizable design. The logo is presented in black and white, with the letters and border appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with C1-5-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	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	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[1]
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

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

[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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.10)

Page 14 of 23

{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 in a stylized, circular design. The logo is black and white, with the letters and the circle's outline in black and the background in white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with ML6-15-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]
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.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 15 of 23

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

Image /page/21/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 are stylized and connected, creating a distinctive and recognizable mark for the company.

Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with RM6C 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	ColorDoppler	Color MDoppler	PowerDoppler	Modes	Combined Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler					Imaging	Pulse	[Notes)
Ophthalmic
Fetal / Obstetrics171	P	P	p		P	P	P	P	P	P	[ 2,6]
Abdominal™	P	P	P		P	P	P	P	P	P	( 2,6)
Pediatric	P	P	P		P	P	P	P	P	P	5,61
Small Organizi
Neonatal Cephalic
Adult Cephalic
Cardiac !31
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
l_aparoscopic

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 biopsv (3D/41)

[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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Poge 16 of 23

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

Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are depicted in black, creating a strong contrast against the white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with RRE5-10-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[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)

{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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 17 of 23

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

Image /page/23/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, creating a unique and recognizable design. The logo is in black and white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with RM14L 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	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
Transurethral
Intraoperative
-Intraoperative-Neurological-
Intravascular
Laparoscopic

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

[2] Small organ includes breast, 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 Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 18 of 23

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

Image /page/24/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and appear to be handwritten or cursive. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with 3Sp-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[1]	P	P	P	P	P	P	P	P	P	P
AbdominalIII	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[1]	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

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

[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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 19 of 23

{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 in black, contrasting with the white background.

GE Healthcare

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with C4-8-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	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6]
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
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 rena!, 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 OO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 20 of 23

{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, circular design. The letters are in a bold, sans-serif font and are surrounded by a circular border with decorative elements.

Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with RAB6-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 / Obstetrics171	p	b	P	P	P	P	P	P	P	P	( 2.6)
Abdominal™	P	P	P	P	P	P	P	P	P	P	[ 2,6]
Pediatric	P	P	P	P	P	P	P	P	b	P	[ 5,6]
Small Organiz)
Neonatal Cephalic
Adult Cephalic
Cardiaclii
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	b	P	P	P	[ 2.6]
Musculo-skeletal Supericial
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 renat, 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

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

Concurrence of CDRH, Office of in Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 21 of 23

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with eM6C 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 / Obstetrics¹⁾	P	P	P		P	P	P	P	P	P	[5,6]
Abdominal¹⁾	P	P	P		P	P	P	P	P	P	[5,6]
Pediatric	P	P	P		P	P	P	P	P	P	[5,6]
Small Organ²⁾
Neonatal Cephalic
Adult Cephalic
Cardiac¹⁾
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

[ l ] Abdominal includes rena!, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

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

[7} 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,

[*] 4D color Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Page 22 of 23

{28}------------------------------------------------

Image /page/28/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, creating a strong contrast against the white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series 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	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 171	P	P	b	P	P	P	P	P	P	b
Abdominal "	b	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	p
Small Organ-T	P	P	P	P	P	b	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac T	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other 11
Exam Type, Meuns of Access
Transesophageal
Transrectall®
Transvaginal
Transuretheral
Intraoperative
-- Intraoperative Neurologica!"
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA:

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,

(Please Do NOT WRITE BELOW THIS LINE - Continue on another Page if needed)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

Page 23 of 23

Prescription User (Per 21 CFR 801.109)

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.