Predicate Devices

K003535, K003090, K003525, K032620, K041688

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the description of the device and its modifications focuses on hardware and general image processing improvements.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "ultrasound evaluation," which means it is used for diagnosis, not for treating conditions.

Diagnostic

Yes
The device description explicitly states, "The Voluson E8 is a full featured, general purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console" and describes physical components like a keyboard, touch screen, and image display. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes the device as being used for ultrasound evaluation of various anatomical sites and patient populations. Ultrasound is an imaging modality that visualizes internal structures of the body.
Device Description: The description details a "diagnostic ultrasound system" that performs digital acquisition, processing, and display of ultrasound images.
Nature of IVDs: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).

This device operates in vivo (within the living body) by using ultrasound waves to create images for diagnostic purposes. It does not perform tests on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of 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 (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).

Product codes

IYN, IYO, ITX

Device Description

The Voluson E8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 57 cm wide, 96 cm deep and 149 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10 inch LCD touch screen and color 15 inch LCD image display. This modification will provide users with additional probe options, improved user interface and overall quality and image enhancement.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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 (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Qualified physician

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)

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. Clinical Tests: None required.

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

Not Found

Predicate Device(s)

K003535, K003090, K003525, K032620, K041688

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

K061682

Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c). JUL 1 2 2006

GE Healthcare

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Section a):

| 1. Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC
PO Box 414
Milwaukee, WI 53201 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allen Schuh,
Manager, Safety and Regulatory Engineering
Telephone: 414-721-3992; Fax: 414-721-3899 |
| Date Prepared: | June 14, 2006 |
| 2. Device Name: | GE Voluson E8 Diagnostic Ultrasound System
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
| 3. Marketed Device: | GE Voluson 730 Diagnostic Ultrasound System, K003535, K003090, K |

GE Voluson 730 Diagnostic Ultrasound System - K003525, K032620, K041688 3. Marketed Device: A device currently in commercial distribution.

Device Description: The Voluson E8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 57 cm wide, 96 cm deep and 149 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10 inch LCD touch screen and color 15 inch LCD image display. This modification will provide users with additional probe options, improved user interface and overall quality and image enhancement.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 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 (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
Comparison with Predicate Devices: The GE Voluson E8 is of a comparable type and substantially equivalent to the current GE Voluson 730 Pro/Expert. It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction and materials and has the same intended uses and basic operating modes as the predicate device.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

2. Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE Voluson E8 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

1

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Mr. Allen Schuh Manager, GE Ultrasound Product Safety and Regulatory Engineering GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226

Re: K061682

Trade Name: GE Voluson E8 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 14, 2006 Received: June 15, 2006

Dear Mr. Schuh:

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

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

Image /page/1/Picture/11 description: The image shows a logo for the FDA Centennial 1906-2006. The logo is circular in shape and contains the letters FDA in a bold, stylized font. Below the letters, the word Centennial is written in a smaller font. The logo is surrounded by text that reads "A Century of Public Health".

Protecting and Promoting Public Health

2

Transducer Model Number

RAB2-5-D	IC5-9-D	9L-D
RAB4-8-D	PA6-8-D	M12LW
RIC5-9-D	SP10-16-D	3S-D
RNA5-9-D	RSP6-16-D	P2D
RRE6-10-D	RIC6-12-D	P6D
AB2-7-D	RAM3-8	M6C
4C-D	RSM5-14	11L-D

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

3

Page 2 -- Mr. Schuh

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ewa Czerska at (301) 594-1212.

Sincerely yours,

David Ch. Leverson

Image /page/3/Picture/6 description: The image shows the word "for" written in cursive. The word is written in black ink on a white background. The letter "f" is larger than the other letters and has a loop at the top. The letters "o" and "r" are connected.

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

Attachment E Indications for Use Forms

The following forms represent indications with clinical applications and The following forms roprocent indicant operation for the Voluson E8 exam types along with the mobelmode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified Voluson 730. In a similar manner, "E" represents with the unmodified Voluson Toodified Voluson 730 via Appendix E of Confinitions added to the subject modification does not alter the the 510(k) Cleared system level indications, clinical applications or modes of operation.

5

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 Ultrasound System

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	E	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	E	P	P	P	P	P	P	[5,6]
Small Organ[2]	P	P	P	E	P	P	P	P	P	P	[5,6]
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[3]	P	P	P	P	P	P	P	P	P	P	[5]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[5,6]
Transvaginal	P	P	P		P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative	P	P	P		P	P	P	P	P	P
Intraoperative Neurological	P	P	P		P	P	P	P	P	P
Intravascular
Laparoscopic

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

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.

[6] Includes imaging of guidance of biopsy (2D/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 Device Evaluation (ODE)

David R. Ingram

6

GE Voluson E8 with RAB2-5-D 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	[5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[5] 3D/4D Imaging Mode

[6] Includes imaging of quidance 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 Device Evaluation (ODE)

Davidh. Seymon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 206/682

7

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 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
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	P	[5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	E	E	E	E	E	E	E	E	E	E	[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[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)

510(k) Number _

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

8

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with RIC5-9-D 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	[5,6]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P	P	P	P	P	P	P	[5,6]
Transvaginal	P	P	P	P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[6] Includes imaging of quidance 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 Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
Prescription User (Per 21 CFR 801.109) and Radiological Devices 12061682
510(k) Number

9

GE Voluson E8 with RNA5-9-D 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	E	P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	E	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	E	P	P	P	P	P	P	[5,6]
Small Organ[2]	P	P	P	E	P	P	P	P	P	P	[5,6]
Neonatal Cephalic	P	P	P	E	P	P	P	P	P	P	[5]
Adult Cephalic
Cardiac[3]	P	P	P	E	P	P	P	P	P	P	[5]
Peripheral Vascular	P	P	P	E	P	P	P	P	P	P	[5,6]
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[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 Device Evaluation (ODE)

Daniel A. Seymore

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _

10

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with RRE6-10-D 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]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P	P	P	P	P	P	P	[5,6]
Transvaginal	E	E	E	E	E	E	E	E	E	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[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 Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

11

GE Voluson E8 with AB2-7-D 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	P	P	P	P	P	P	P	P	P	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
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 Device Evaluation (ODE)

David R. Seggerman

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number _

12

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with 4C-D 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	E	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	E	P	P	P	P	P	P	[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	E	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 Device Evaluation (ODE)

David A. Swanson

(Division Sign-Off) Division of Reproductive, Abdomir and Radiological Devices 510(k) Number

13

GE Voluson E8 with IC5-9-D Transducer

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

	Mode of Operation
Clinical Application
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]
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	[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; E = added under Appendix E

Notes: {6} Includes imaging of guidance of biopsy (2D)

[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 Device Evaluation (ODE)

Daniel h. Sprom

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

14

GE Voluson E8 with PA6-8-D Transducer

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

	Mode of Operation
Clinical Application
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]
Abdominal[1]	E	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E	E
Small Organ[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[3] Cardiac is Adult and Pediatric.

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

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Ingram

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __

15

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with SP10-16-D Transducer

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

	Mode of Operation
Clinical Application
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]
Abdominal[1]
Pediatric	E	E	E	E	E	E	E	E	E	[6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E	E	E	E	E	E	E	[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	[6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric 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 Device Evaluation (ODE)

David h. Syverson

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number

16

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with RSP6-16-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Modes	Combined Harmonic
Imaging	Coded
Pulse	Other
(Notes)
Ophthalmic
Fetal / Obstetrics (7)
Abdominal(1)
Pediatric	는	E	E	E	E	E	는	는	트	( 5,6)
Small Organ(2)	E	E	E	E	E	E	E	E	트	ા રે દો
Neonatal Cephalic
Adult Cephalic
Cardiac-31
Peripheral Vascular	m	E	רח	E	E	ന	E	E	는	(5,6)
Musculo-skeletal Conventional	E	E	ന	E	E	E	E	E	E	5,61
Musculo-skeletal Superficial	E	E	E	E	E	E	E	는	E	5,61
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative	E	E	E	E	E	E	E	E	ട്
Intraoperative Neurological	E	E	E	E	E	E	E	E	E
Intravascular
Laparoscopic

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

Notes: [2] Small organ includes breast, testes, 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 Device Evaluation (ODE)

David A. Seppman

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices Prescription User (Per 21 CFR 801.109) 510(k) Number _

17

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 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
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]	E	E	E	E	E	E	E	E	E	[5,6]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	E	E	E	E	E	E	E	E	E	[5,6]
Transvaginal	E	E	E	E	E	E	E	E	E	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel De Seggern

(Division Sign-Off) Prescription User (Per 21 CFR 801.109Pivision of Reproductive, a and Radiological Devices 510(k) Number

18

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with RAM3-8 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]	N	N	N	N	N	N	N	N	N	[5,6]
Abdominal[1]	N	N	N	N	N	N	N	N	N	[5,6]
Pediatric	N	N	N	N	N	N	N	N	N	[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	[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, Urology

[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 Device Evaluation (ODE)

David h. Seymon

(Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices 510(k) Number

19

GE Voluson E8 with RSM5-14 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]
Abdominal [1]
Pediatric	N	N	N	N	N	N	N	N	N	[5,6]
Small Organ[2]	N	N	N	N	N	N	N	N	N	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	[5,6]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	[5,6]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [2] Small organ includes breast, testes, 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 Device Evaluation (ODE)

David A. Sequin

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _

20

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with 9L-D 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]
Abdominal[1]
Pediatric	N	N	N	N	N	N	N	N	N	[6]
Small Organ[2]	N	N	N	N	N	N	N	N	N	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	[6]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	[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: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients [6] Includes imaging of guidance of biopsy (2D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David B. Ingram

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _

21

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with M12LW 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]
Abdominal[1]
Pediatric	E	E	E	E	E	E	E	E	E	[6]
Small Organ[2]	E	E	E	E	E	E	E	E	E	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E	E	E	E	E	E	E	[6]
Musculo-skeletal Conventional	E	E	E	E	E	E	E	E	E	[6]
Musculo-skeletal Superficial	E	E	E	E	E	E	E	E	E	[6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric 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 Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number __

22

GE Voluson E8 with 3S-D 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]	N	N	N	N	N	N	N	N	N	N	N
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N	N
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	N
Cardiac[3]	N	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
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; 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 Device Evaluation (ODE)

Davidh. Seymour
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number

23

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with P2D 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]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic				N
Cardiac[3]				N
Peripheral Vascular				N
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 Device Evaluation (ODE)

David R. Lyons

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

Prescription User (Per 21 CFR 801.109) 510(k) Number ___

.

24

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with P6D 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]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]				N
Peripheral Vascular				N
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 Device Evaluation (ODE)

Daniel R. Nygaard

(Division Sign-Off)

Division of Reproductive, Abdo Prescription User (Per 21 CFR 801.109 Ind Radiological Devices

25

Diagnostic Ultrasound Indications for Use Form

GE Voluson E8 with M6C 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]	N	N	N	N	N	N	N	N	N	N	[6]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[6]
Pediatric	N	N	N	N	N	N	N	N	N	N	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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 Device Evaluation (ODE)

Daniela Segovia

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

26

GE Voluson E8 with 11L-D 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]
Abdominal[1]
Pediatric	N	N	N	N	N	N	N	N	N	[6]
Small Organ[2]	N	N	N	N	N	N	N	N	N	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	[6]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	[6]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	[6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric 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 Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	2061682
Prescription User (Per 21 CFR 801.109)