VOLUSON P6, VOLUSON P8

• K Number: K141675
• Device Name: VOLUSON P6, VOLUSON P8
• Manufacturer: GE HEALTHCARE
• Date Cleared: 2014-07-25 ( 30 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric: Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Device Description

The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

Predicate Devices

K132913, K122387

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms, and the description focuses on standard ultrasound imaging and processing capabilities.

Therapeutic

No.
The device is described as an "imaging and analysis system" and an "ultrasound system" which are used for diagnostic purposes, not therapeutic ones.

Diagnostic

Yes
The device is described as a general-purpose ultrasound system with specific clinical applications and exam types covering various anatomical sites and patient age ranges, indicating its use in diagnosing medical conditions by providing real-time digital acquisition, processing, and display capabilities for imaging and evaluation.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The intended uses listed are all related to imaging and evaluation of anatomical structures within the body using ultrasound. This is a core function of diagnostic imaging devices, not IVDs. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to obtain information about a person's health.
• Device Description: The description details a "general-purpose ultrasound system" with transducers and a display. This aligns with the description of an imaging device.
• Input Imaging Modality: The input modality is "Ultrasound," which is an imaging technique, not a method for analyzing biological specimens.
• Anatomical Site: The listed anatomical sites are all locations within the human body that are imaged.

There is no mention of analyzing biological samples or providing diagnostic information based on such analysis, which are the defining characteristics of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric: Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Product codes

1YN, IYO, ITX

Device Description

The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 general-purpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Indicated Patient Age Range

Adult and Pediatric, Neonatal

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K132913, K122387

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

JUL 25 2014

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The letters are stylized with curved lines and a flowing design, and the circle has three decorative swirls around it.

K141675
Page 1 of 4

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: June 24, 2014

GE Healthcare . Submitter: 9900 Innovation Dr Wauwatosa, WI 53226

Primary Contact Person:

Secondary Contact Person:

Bryan Behn Regulatory Affairs Manager GE Healthcare T:[phone] F:[phone] Chansook KIM Regulatory Affairs Leader GE Healthcare T:([phone]

Voluson P6, Voluson P8 Ultrasound System Device: Trade Name: Common/Usual Name: Voluson P6. Voluson P8 Classification Names:

Product Code:

Class II

Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Predicate Device(s):

K132913 Voluson E Series

K 122387 Voluson P6/P8

The subject device consists of a mobile console with keyboard, Device Description: specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric: Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV);

Intended Use:

1

Image /page/1/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, and there are decorative swirls or flourishes around the letters within the circle.

GE Healthcare

510(k) Premarket Notification Submission

Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

The Voluson P6. Voluson P8 employs the same fundamental Technology: scientific technology as its predicate devices

Determination of Substantial Equivalence:

Comparison to Predicate Device(s):

The Voluson P6/P8 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

• The systems are all intended for diagnostic ultrasound . imaging and fluid flow analysis.
• . The Voluson P6/P8 and predicate Voluson P6/P8 systems have the same clinical intended use
• The Voluson P6/P8 and predicate Voluson P6/P8 systems . have the same imaging modes.
• . The Voluson P6/P8 and predicate Voluson P6/P8 systems transducers are identical.
• The systems are manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
• . The systems have acoustic power levels which are below the applicable FDA limits.
• The Voluson P6/P8 and predicate Voluson P6/P8 systems . have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
• New software features added to Voluson P6/P8: HDLive, . Sono IT, SonoBiometry and Sono L&D are the same features cleared on predicate Voluson E Series(K132913).
• . The Voluson P6/P8 and predicate systems have been designed in compliance with approved electrical and physical safety standards.

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 to applicable medical device safety standards. Voluson P6/P8 and its applications comply with

2

Image /page/2/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 frame. The letters and the frame are solid black, contrasting with the white background. The logo is simple and recognizable, representing the well-known multinational corporation.

voluntary standards;

• l. AAMI/ANSI ES60601-1, 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
• 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 are 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.

3

Image /page/3/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 frame. The frame has a swirling pattern around the letters. The logo is black and white.

GE Healthcare

510(k) Premarket Notification Submission

Summary of Clinical Tests:

The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Voluson P6, Voluson P8 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing the department's three main goals: health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Public Health Service

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

July 25, 2014

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

Re: K141675

Trade/Device Name: Voluson P6, Voluson P8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 24, 2014 Received: June 25, 2014

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 S6, Voluson S8 Diagnostic Ultrasound System, as described in your premarket notification:

	Transducer Model Number
RAB2-6-RS	4C-RS	E8C-RS
12L-RS	RICS-9W-RS	RAB2-5-RS
38c-RS

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.

5

Page 2—Mr. Behn

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.goy/MedicalDevices/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.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

6

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141675

Device Name

Voluson P6/Voluson P8 Diagnostic Ultrasound System

Indications for Use (Describe)

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, thyroid, salivary gland, lymph nodes, pediatric and neonatal Cephalic; Adult Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

7

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Diagnostic Ultrasound Indications for Use Form GE Voluson P6/P8 Ultrasound System

		Mode of Operation
Clinical Application	Anatomy/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		P	P	P	P	P	P	P	P	P	P	[5,6,9]
Fetal / Obstetrics[7]		P	P	P	P	P	P	P	P	P	P	[5,6,9]
Abdominal[1]		P	P	P	P	P	P	P	P	P	P	[5,6,9]
Pediatric		P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]		P	P	P	P	P	P	P	P	P	P	[5,6,9]
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[4]		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

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

N = new indication; P = previously cleared by FDA

No1cs: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

15| 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate

[9] Elastography imaging. Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/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)

8

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with RAB2-6-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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 / Obstetrics71	P	P	P		P	P	P	P	P	P	(5,6)
Abdominal1	P	P	P		P	P	P	P	P	P	(5.6)
Pediatric
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
Transrectal4)
Transvaginal
Transurethral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication: P = previously cleared by FDA

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

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

|3| Cardiac is Adult and Pediatric

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE DELOW TIJIS LINE - CONTINUE ON ANOTIER 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 9

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Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with 4C-RS Transducer

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

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

N - new indication: P = previously cleared by FDA

| | | Abdominal includes renal, G YN/Pelvic Noics:

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

15] 3D/4D Imaging Mode

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

[7] Includes infertifity monitoring of follicle development.

[8] Includes urology/prosialc.

19. Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M. B/PWD, B/Color/PWD, B/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 9

10

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Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with E8C-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[6]
Pediatric
Small Organ[2]
Neonatal Cephalic	P	P	P		P	P	P	P	P	P	[6]
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[4]	P	P	P		P	P	P	P	P	P	[6]
Transvaginal	P	P	P		P	P	P	P	P	P	[6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication: P = previously cleared by FDA

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

[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.

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

[7] Includes infertility monitoring of follicle development.

(8) Includes urology/prostate

[9] Elastography imaging- Elasticity

[ ] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW TIJIS 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 9

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Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with 12L-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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
AbdominalII
Pediatric	P	P	P		P	P	P	P	P	P	[6,9]
Small OrganII	P	P	P		P	P	P	P	P	P	[6,9]
Neonatal Cephalic
Adult Cephalic
CardiacI
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
TransrectalII
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication: P = previously cleared by FDA

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

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

[3] Cardiac is Adult and Pediatric

[5] 3D/4D Imaging Mode.

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

{7} Includes infertility monitoring of follicle development.

18] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

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Page 6 of 9

12

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The letters are stylized and connected, and the circle has a textured or shaded appearance.

Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with RICS-9W-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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[1]	P	P	P		P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[1]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[4]	P	P	P		P	P	P	P	P	P	[5,6]
Transvaginal	P	P	P		P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes rena!, GYN/Pelvic

(2) Small organ includes breast, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prosiate

19| Elastography imaging- Elasticity

[ ° ] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

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Prescription User (Per 21 CFR 801.109)

Page 7 of 9

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 logo is black and white and has a vintage look.

Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with RAB2-S-RS Transducer

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

| Clinical Application
Anatomy/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 | | | | | | | | | | | |
| Small Organ1 | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| Transrectal1 | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N - new indication; P - previously cleared by FDA

[1] Abdominat includes renal. GYN/Pelvic Nolcs:

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

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

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

[ 7] Includes infertility monitoring of follicle development.

{8} Includes urology/prosiate.

[9] Elastography imaging- Elasticity

[ °] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

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

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Page 8 of 9

14

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with 3Sc-RS Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Anatomy/Region of Interest
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	P	P	P	P	P	P	P	P	P	P	[6]
Small Organ2
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[6]
Cardiac11	P	P	P	P	P	P	P	P	P	P	[6]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal11
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication: P = previously cleared by FDA

No1cs: [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.

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

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate

[9] Elastography imaging- Elasticity

(*) Combined modes are B/M, B/Color M. B/PWD, B/Color/PWD, B/PWD

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

Prescription User (Per 21 CFR 801.109)

Page 9 of 9