VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10

• K Number: K132913
• Device Name: VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
• Manufacturer: GE HEALTHCARE
• Date Cleared: 2013-11-08 ( 52 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Special
• Panel: Radiology
• Reference & Predicate Devices: K131267
• Predicate For: K141639 , K141675 , K142472 , K150080 , K152543 , K152763

Intended 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); Musculo-skeletal Conventional and Superficial: Peripheral Vascular: Transvaginal: Transrectal

Device Description

The Voluson E-Series system is a full-featured Track 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 GE Voluson E Series Diagnostic Ultrasound Systems did not require a clinical study to support substantial equivalence. The submission states: "The subject of this premarket submission. Voluson E Series, did not require clinical studies to support substantial equivalence." (Page 3).

Therefore, there are no specific acceptance criteria or a study proving the device meets them in the provided document, as no clinical studies were performed. The device's substantial equivalence refers to its similarity to predicate devices already on the market.

However, the submission does include several non-clinical tests and quality assurance measures applied to the development of the system to ensure its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were conducted, there are no reported device performance metrics from human or in-vitro tests against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The acceptance criteria essentially rely on conformance to established safety and performance standards for ultrasound equipment.

Acceptance Criterion (Type)	Reported Device Performance
Acoustic output (Conformance to NEMA UD 3 & NEMA UD 2)	Conforms with applicable medical device safety standards.
Biocompatibility (Conformance to ISO 10993-1)	Conforms with applicable medical device safety standards.
Cleaning and disinfection effectiveness	Conforms with applicable medical device safety standards.
Thermal, electrical, electromagnetic, and mechanical safety (Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37)	Conforms with applicable medical device safety standards.
Risk Analysis (Quality Assurance Measure)	Applied to the development of the system.
Requirements Reviews (Quality Assurance Measure)	Applied to the development of the system.
Design Reviews (Quality Assurance Measure)	Applied to the development of the system.
Testing on unit level (Module verification) (QA Measure)	Applied to the development of the system.
Integration testing (System verification) (QA Measure)	Applied to the development of the system.
Final Acceptance Testing (Validation) (QA Measure)	Applied to the development of the system.
Performance testing (Verification) (QA Measure)	Applied to the development of the system.
Safety testing (Verification) (QA Measure)	Applied to the development of the system.
DICOM Set Conformance (Conformance to NEMA)	Complies with voluntary standards.
Transducer materials biocompatibility	Biocompatible.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation assistance for humans. No MRMC study was mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The Voluson E Series is a diagnostic ultrasound system whose operation inherently involves a human operator to acquire and interpret images. There's no "algorithm only" performance reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for the non-clinical tests would be the established specifications and regulatory standards that the device was tested against.

8. The sample size for the training set: Not applicable, as this is related to clinical studies or machine learning model development, neither of which are described in the context of this submission. The device is a traditional ultrasound system.

9. How the ground truth for the training set was established: Not applicable, as no training set for a clinical study or machine learning model is mentioned.

Summary

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K132913
Page 1 of 3

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	September 16, 2013
Submitter:	GE Healthcare [GE Healthcare Austria GmbH & Co OG]Tiefenbach 15Zipf, Austria 4871
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE HealthcareT:[phone]F:[phone]
Secondary Contact Person:	Roland KuntscherRegulatory Affairs SpecialistGE Healthcare Austria GmbH & Co OGT:(++43)7682-3800-660F:(++43)7682 3800-47NOV 0 8 2013
Device:Trade Name:	Voluson E Series
	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 90-1YNUltrasonic Pulsed Echo Imaging System. 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer. 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K131267 Voluson E-Series E6/E8/E8Expert/E8Expert LE/E10Diagnostic Ultrasound System
Device Description:	The Voluson E-Series system is a full-featured Trackultrasound 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.

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GE Healthcare

510(k) Premarket Notification Submission

Device Modification:

This modification consists of a change to the labeling for the previously cleared SonolT feature. Additionally. the previously cleared probe RAB4-8-D had been re-introduced to the Voluson E Series and a correction to the transducer application Obstetrics on the 91 -D have been made since the previous clearance.

Intended 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); Musculo-skeletal Conventional and Superficial: Peripheral Vascular: Transvaginal: Transrectal

The Voluson E-Series employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

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. IEC60601-1. Medical Electrical Equipment Part 1: General Requirements for Safety
• 2. IEC60601-1-2. Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
• 3. IEC60601-2-37. Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• 4. NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 5. ISO10993-1. Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
• 6. NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

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K132913
Page 3 of 3

GE Healthcare

510(k) Premarket Notification Submission

• 7. ISO14971. Application of risk management to medical devices
• 8. 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) 0
• . 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.

Conclusion:

GE Healthcare considers the Voluson E Series to be as safe. as effective, and performance is substantially equivalent to the predicate device(s).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

November 8, 2013

GE HEALTHCARE BRYAN BEHN REGULATORY AFFAIRS MANAGER 9900 W INNOVATION DRIVE WAUWATOSA WI 53226

Re: K132913

Trade/Device Name: Voluson E6 / F8 / 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: October 22, 2013 Received: October 24, 2013

Dear Mr. Behn:

We have reviewed vour 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 10 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 Yoluson E6 / E8 / E8expert / E8expert Limited Edition / E10 Diagnostic Ultrasound Systems, as described in your premarket notification:

	Transducer Model Number
RAB2-2-D	(21)	3Sp-D
RIC5-9-1)	P6D	C4-8-D
RNA5-9-1)	I I L-D	RAB6-D
4C-D	CI-5-ID	eM6C
ICS-9-1)	MIL.6-15-ID	S4-10-D
रऽP6-16-D	RM6C	RAB4-8-D
RIC6-12-12	RRES-10-D
9L-D	RM 41.

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Page 2-Mr. Behn

If your device is classified (see above) into either class 11 (Special Controls) or class 111 (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 [phone] or [phone] or at its Internet address

http://www.lda.gov/MedicalDevices/Resources/or 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/default.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sm.7)

for

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

Enclosure

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510(k) Number (if known): K132913

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: Cardiae (adult and pediatric): Musculoskeletal Conventional and Superficial: Peripheral Vascular: Transvaginal: Transrectal

Preseription Use - X -(Part 21 CFR 801 Subpart D) ANDJOR

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

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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 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/E8ExperVE10 and "E" arc 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.

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Image /page/7/Picture/0 description: The image shows a black and white logo. The logo is circular and contains a stylized monogram of the letters 'G' and 'E'. The letters are intertwined and surrounded by a decorative border. The logo appears to be a vintage or classic design.

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[1]	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	[ 5,6,9 ]
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[1]	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, pediative and neonatal patients [3] Cardiac is Adull 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/prosiate.

(9) Elastography imaging- Elasticity

(' ) Combined modes are B/M. B/Color M, B/PWD or CWD. B/Color/PWD or CWD. B/Power/PWD.

(*) 4D color Doppter

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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 / Obstetrics1	P	P	P	P	P	P	P	P	P	P	[5, 6]
Abdominal1	P	P	P	P	P	P	P	P	P	P	[5, 6]
Pediatric
Small Organ1
Neonatal Cephalic
Adult Cephalic
Cardiac1
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

Notes: [ ] ] Abdominal includes tenal. 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, IV/W1) or CW1), B/Color/PW1) or CWD, B/Poster/PW1D

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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:

Clinical ApplicationAnatomy Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics1	P	P	P		P	P	P	P	P	P	[5,6,9]
AbdominalII
Pediatric
Small OrganII
Neonatal Cephalic
Adult Cephalic
CardiacII
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
TransrectalII	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 fr

[5] 3D/4() Imaging Mode Nolcs

[6] Includes amaging of guidance of bropsy (3D-40)

| 7 | Includes inferritity monitoring of follicle development

|8| Includes urology/prostate

19. Elastography Imagings Masticity

1° | Combined modes are IVM, BC ulor M, HiPWD or CWD, B/Color?PWD or CWD, B/Power/PWD.

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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	("WDoppler	ColorDoppler	Color MDoppler	PowerDepoter	Modes	ombined I larmonicImaging	CodedPulse	Olber(Nolcs)
Ophthalmic
Fetal / Obsteiries!"	P	P	P	12	P	P	p	P	P	P	2.6)
Abdominal 11	P	P	P	P	P	P	P	P	P	b	રુંદર્ણ
l'ediatric	P	P	P	P	P	P	P	P	P	P	2.6
Small Organia	P	P	P	မြ	P	r	ગુજર	P	r	្រ	િર્મ્ણ
Neonatal Cophalic	P	P	P	P	b	P	P	P	P	P	ા રા
Adult Cephalic
ייבוליתונו }	P	P	ll	P	P	P	P	P	P	ប្រ	રો
Peripheral Vascular	P	p	P	12	P	P	p	P	P	p	ા રજકો
Musculo-skeletal Conventional	P	P	P	P	P	P	p	P	P	b	5.6)
Musculo-skeletal Superficial
Other
Exem Type, Means of Access
Transesophageal
Transrectol™
Transvaginal
I ransuretheral
Intraoperative
Intraoperative Neurological
Intravoscular
Laparoscopic

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

| | | Abdominal is Nennatal and pediatric Norts:

[2] Small organ includes breast, thyroid, suivary gland, I mph nodes, pediatric and nennation patients

[3] Cardiac is Neonatal and Pediatric

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[6] Includes imaging of guidance of biopsy (31)/4())

[*] Combined modes are 13/M, B/Color M, B/PW1) or CWD, B/C'olor/PW1D or C'WD, WPower/PW12.

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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	OtherNotes
Ophthalmic
Fetal / Obstetrics[1]	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[1]
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

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

16] Includes imaging of guidance of hiopsy (20)

| 7 | Includes infectility 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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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:

Clinical ApplicationAnatomy: Region of Interest	Mode of Operation											Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse
Ophthalmic
Fetal / Obstetrics	P	P	P		P	P	P	P	P	P	[6,9]
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal	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 FI>A: 1 = added under Appendix E

[6] Includes maging of goldance of hiopsy (20) Notes

| 7 | Includes infertitity monnoring of follicle development

| 8| Includes urology/prostate

|9} Elastography Imaging. Hiasticus

| * | Combined modes are B/M, B/Color M, B/PWD or CWD, IWC olor/PWD or CWD, B/Power/PWD,

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Page 7 of 24

{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 in a stylized, cursive font. The intertwined letters are enclosed within a circular border. The logo is black and white.

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:

Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics1
Abdominal1
Pediatric	P	P	P		P	P	P	P	P	P	[5,6]
Small Organ1	P	P	P		P	P	P	P	P	P	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac1
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
Transrectal1
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication, P = previously cleared by FDA: E = udded under Appendiv E

12. Small organ includes breast, thyroid, salivary gland, lymph nodes, pechairie and neonatal patients Notes

|5) 31)/41) Imaging Mode

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

[*] Combined modes are B/M, B/Calor M. B/PW1) or CWD, B/Calor/PW1) or CWD, B/Power/PWD

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Page 8 of 24

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

Image /page/14/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'G' and 'E' intertwined in the center. The letters are stylized and have a vintage look. The logo is likely for General Electric (GE).

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:

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	[5, 6]
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[1]	P	P	P		P	P	P	P	P	P	[5, 6]
Transvaginal	P	P	P		P	P	P	P	P	P	[5, 6]
Transuretherul
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication, I' = previously cleared by FDA. E = added under Appendix F.

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

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

[7] Includes infertility monitaring of follicle development

[8] Includes urology/prosunc

[*] Combined modes are R/M, I3/Color M, HJ/WD or CWI), HXColor/PWI) or CWD, B/Power/PW/D.

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Page 9 of 24

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

Image /page/15/Picture/0 description: The image shows a logo of the General Electric (GE) company. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are surrounded by a decorative border, giving the logo a classic and recognizable appearance.

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:

Clinical ApplicationAnatomy Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics	E	E	E	E	E	E	E	E	E	E	[6]
Abdominal
Pediatric	P	P	P	P	P	P	P	P	P	P	[6]
Small Organ	P	P	P	P	P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac
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

N - new indication, P = previously cleared by FDA, I: = added under Appendis F.

[2] Small organ meludes breast, thyroid, saltvary gland, fymph nodes, pediatric and newnated pattents Noles

(6) Includes maging of guidance of biopsy (2D)

[7] Includes intertility monument of follicle development

[*] Combined modes are H/M, B/Color M, B/PW1) ar CWD, B/C'alpr/PW1) or CW12, H/Pawer/PW()

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

Image /page/16/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'G' and 'E' intertwined in the center. The letters are stylized and have a vintage appearance. The logo is surrounded by a thick black border.

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	OtherNotes
Ophthalmic
Fetal / Obstetrics1
Abdominal1
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic				P
Cardiac1				P
Peripheral Vascular				P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type. Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

N = new indication, P = previously cleared by FDA: F. = added under Appends fi

Notes. [3] Cardiae is adult and Pediatric

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Page 11 of 24

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

Image /page/17/Picture/0 description: The image shows a logo of General Electric (GE). The logo is a circular design with the letters 'GE' intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The logo is black and white, with the letters and the surrounding circle being black and the background being white.

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:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac				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 cleaned by FDA; E = added under Appendix fi

Notes: [3] Cardiae is adult and Pediatric

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Page 12 of 24

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

Image /page/18/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 letters are surrounded by a circular border with a decorative pattern.

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	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P		P	P	P	P	P	P	[6,9]
Small Organ	P	P	P		P	P	P	P	P	P	[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac
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, I' = previously cleared by FDA. F. = added under Appendis F

12. Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, nediatric and neonalal patients Nules:

[b] Includes imaging of guidance of hiopsy (2D)

19] Elastography Imaging- Elasticity

[*] Comhined modes are B/M. B/Color M. B/PWD or CWD. B/Color/PWD or CWD. B/Paver/PWD

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Page 13 of 24

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

Image /page/19/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' intertwined in the center. The letters are stylized and appear to be hand-drawn. The circle surrounding the letters has a textured or patterned design, giving it a vintage or classic look.

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 / Obstetrics1	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal11	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac4
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

| I J Abdominal includes renal, GYN/Pelvic, Urology Notes

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

[7] includes intertility 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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Page 14 of 24

Diagnostic Ultrasound Indications for Use Form

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

Image /page/20/Picture/0 description: The image shows a logo of General Electric (GE). The logo consists of the letters "GE" intertwined within a circular border. The design is intricate and stylized, with the letters forming a complex pattern. The logo is in black and white.

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	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics¹
Abdominal¹
Pediatric	P	P	P		P	P	P	P	P	P	[6,9]
Small Organ¹	P	P	P		P	P	P	P	P	P	[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac¹
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. 1: = 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 (21)}

19] Elastography Imaging-filasticity

| * | Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD,

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Page 15 of 24

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

Image /page/21/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 intertwined letters are enclosed within a circular border. The logo is black and white.

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 ApplicationAnatomy: Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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
Cardiac3
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 Appends, E

| | | Abdominal includes tenal. GYN.Pelvic. Urology Noles

15| 31)/41) Imaging Mode

16] Includes imaging of guidance of bropsy (31):41)

| 7 | Includes infertility monitoring of fallicle development

| * | Combined modes any |}/M. |}/Color M, B/PWI) or CWID, B/Color/PWD or C'WID, |V/Power/PWD,

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Page 16 of 24

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

Image /page/22/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 letters are surrounded by a decorative border, giving the logo a vintage or classic appearance. The logo is simple and recognizable.

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 / Obstetrics1
Abdominal1
Pediatric
Small Organ1
Neonatal Cephalic
Adult Cephalic
Cardiac1
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type. Means of Access
Trunsesophageal
Transrectal1	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: H = added under Appendix f:

(5) 3D/4D Imaging Mode Notes:

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

|8] Includes nrology/prostanc

|9) Flastography Imaging- Elasticus

[*] Combined modes are B/M. B/Color M. R/PWD or CWD. B/C okor!!W1) or CWD, B/Power/PWD

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Page 17 of 24

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

Image /page/23/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 design is simple and recognizable, representing the company's brand identity.

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:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics1
Abdominal1
Pediatric	P	P	P		P	P	P	P	P	P	[5,6]
Small Organ1	P	P	P		P	P	P	P	P	P	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac1
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; F = udded under Appendix E

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

{5} 3D/4D Imaging Mude

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

[ * ] Combined modes are B/M, B/Cular M, 13/1'WD ar CWD, B/Color/PWD or CWD, B/Power/PWD,

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Page 18 of 24

{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 circular frame. The design is simple and recognizable, representing the company's brand identity.

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:

Clinical ApplicationAnatomy Region of Interest	Mode of Operation
	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
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(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, 11 = added under Appendis E

[1] Abdominal includes renal. GYN:Pels ic Notes

| 3| Cardiac is adult and Pediatric

[ 7] Includes infertility monitoring of follicle development

[ *] Combined modes are 13/M, B/Color M, B/PWI) or CW1), B/Color/PWD or CWD, B/Poster/PWD

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Page 19 of 24

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

Image /page/25/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The border is also decorative, with a repeating pattern that resembles leaves or flames. The logo is black and white and has a vintage or classic look.

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 Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics!!	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal!!	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!
Neonatal Cephalic
Adult Cephalic
Cardiac!!
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. I' = previously cleared by FDA. E = added under Appendix E

[ f | Abdominat includes renal. GYN/Pelvic. Urology Notes

[6] Includes maging of guidance of hiopsy (21))

[7] Includes infertility mannoring of follicle development

[*] Combined modes are B/M. B/Color M. B/PWD or (*WD, B/ColorPW1D or CWD, B/Power/PWD,

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Page 20 of 24

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

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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 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	[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[1]
Neonatal Cephalic
Adult Cephalic
Cardiac[1]
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
Transurethral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

II ] Abdominal includes renat. GYN/Pelvic. Urology Noles:

[5] 3D/4D Imaging Mode

(6) Includes imaging of guidance of hiopsy (3D/4D)

| 7 | Includes infertility monitoring of follicle development

| 1 Combined modes are B/M, B/Color M, B/PWI) or CWD, H/Color/PW1) or CWD. B/Power/PW12

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Page 21 of 24

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

Image /page/27/Picture/0 description: The image shows a black and white logo of the General Electric (GE) company. The logo consists of the letters 'GE' intertwined within a circular border. The design is intricate and stylized, giving it a classic and recognizable appearance.

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 Application	13	M	ויאל	("W	Color	Color M	Power		ombined I larmonic	( `oded	(Jher
Anatoniv Region of Interest			Doppler	Dappler	Doppler	Doppler	Doppler	Modes	Imaging	Pulss	Notes }
Ophthalme
Feml / Obstetries' '	P	l'	p		l'	P	P	伊	P	પ્ર	રૃત્યુ
Abdominal ":	P	P	y		P	P	്ര	P	P	P	ા ર ર્શ્વ
Pediatric	P	P	P		P	P	p	ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ	P	િ	हंकी
Small ()rgan':'
Neonatal Cephalic
Adult Cephalic
Cardiac الايت التقليل التي تق
Peripheral Vascular
Musculo-skeletal Conventional	P	P	p		b	P	P	P	P	P	ો રહી
Musculo-sketetal Superficial
Other
Exam Type. Meuns of Access
Trunsesophageal
Transcectal
Transvagnal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
l aparoscopic

N = new indication. P = previously cleared by FDA, E = added under Appends F

[1] Abdominal includes renal. GY N/Pelvic, Urology Notes

|| || 31)/41) Imaging Mode

[6] Includes imaging of guidance of hiopsy (30/40)

| 7 | Includes intertility momnoring of follotle development

(*) Combined modes are B/M, B/Colur M, B/PWD or CWD, B/Colori/WD ur CWD, B/P/nver/PW/D

[ ] 4D color Doppler

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Page 22 of 24

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Image /page/28/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 classic and recognizable, representing the company's long history and brand identity.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with $4-10-D Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Anatomy-Region of Interest
Ophthalmic
Fetal / Obstetrics1	P	P	P	P	P	P	P	P	P	P
Abdominal1	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ1	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac1	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other4
Exam Type, Means of Access
Transesophageal
Transrectal4
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes

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

(2) Small organ includes breast, thytoid, salvary gland, is mph nodes, pediativ and neations

(3) Cardiac is Adult and Pedrairie

| 7} Includes infertifity monitoring of follicle development

|*| Combined modes are B/M, B/Color M, B/PWD or CWD, B/Calar/PWD ar CWD, MPosser/PWD

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Page 23 of 24

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

Image /page/29/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo is circular and features the letters 'G' and 'E' intertwined in a stylized manner. The letters are surrounded by a decorative border, giving the logo a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with RAB4-8-D Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics1	E	E	E		E	E	E	E	E	E	[ 5,6 ]
Abdominal1	E	E	E		E	E	E	E	E	E	[ 5,6 ]
Pediatric	E	E	E		E	E	E	E	E	E	[ 5,6 ]
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac1
Peripheral Vascular
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	E	[ 5,6 ]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Amniocentesis

N = new indication: P = previously cleared by FDA: 15 = udded under Appendix E (Previously cleared K12237)

| | | Abdominal includes renal. GYN/Pelvic Noles:

[5] 31)/41) Imaging Mode

[6] Includes imaging of guidance of hiopsy (3D/41)

[ 7] includes infertifity monnoring of follicle development

[ * ] Combined mudes are B/M, B/Colur M, R/PW1) or CW1), B/Color/PWD or CW1), B/Power/PW1D

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$\sin(x,y)$

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Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) Number_K132913

Page 24 of 24

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.