Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with image processing capabilities but makes no mention of AI or ML technologies.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "ultrasound evaluation," indicating imaging and diagnostic purposes rather than therapeutic intervention.

Diagnostic

Yes
The "Device Description" explicitly states, "The Voluson 730 Pro or Expert is a full featured general purpose diagnostic ultrasound system." The "Intended Use / Indications for Use" also describes its use for "ultrasound evaluation" across various anatomical sites, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "full featured general purpose diagnostic ultrasound system" consisting of a "mobile console" with hardware components like a keyboard, controls, and displays. 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 states that the device is for "ultrasound evaluation" of various anatomical sites. Ultrasound is an imaging modality used to visualize internal structures of the body.
Device Description: The description details a "diagnostic ultrasound system" that performs "digital acquisition, processing and display capability." This aligns with the function of an imaging device, not a device that analyzes samples taken from the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVDs are specifically designed for such purposes.

The device is a diagnostic imaging system used to visualize and evaluate internal structures, which is distinct from the function of an In Vitro Diagnostic device.

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; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Orqan (breast, testes, thyroid etc.); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).

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

For GE Voluson 730 Pro/Expert Ultrasound System:
Clinical Application / Anatomy/Region of Interest, Modes of Operation:

Fetal / Obstetrics [7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Abdominal [1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Pediatric: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Small Organ [2]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Neonatal Cephalic: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Adult Cephalic: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Cardiac [3]: B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Peripheral Vascular: B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Transrectal: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Transvaginal: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Intraoperative: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse
Intraoperative Neurological: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse

Notes specific to transducers:
GE Voluson 730 Pro/Expert with AB2-7 Transducer:

Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Abdominal[1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Pediatric: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])

GE Voluson 730 Pro/Expert with AC2-5 Transducer:

Fetal / Obstetrics(7): B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Abdominal(1): B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])

GE Voluson 730 Pro/Expert with SP4-10 Transducer:

Pediatric: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Small Organ[2]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])

GE Voluson 730 Pro/Expert with SP6-12 Transducer:

Pediatric: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Small Organ[2]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])

GE Voluson 730 Pro/Expert with SP10-16 Transducer:

Small Organ[2]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])

GE Voluson 730 Pro/Expert with PA2-5P Transducer:

Abdominal[1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse
Adult Cephalic: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse
Cardiac[3]: B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse

GE Voluson 730 Pro/Expert with PA6-8 Transducer:

Neonatal Cephalic: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse
Adult Cephalic: B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse
Cardiac[3]: B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse

GE Voluson 730 Pro/Expert with IC5-9 Transducer:

Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Transrectal: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])
Transvaginal: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Note: [6])

GE Voluson 730 Pro/Expert with SCW2.0 Transducer:

Cardiac[3]: CW Doppler

GE Voluson 730 Pro/Expert with PCW4.0 Transducer:

Cardiac[3]: CW Doppler
Peripheral Vascular: CW Doppler

GE Voluson 730 Pro/Expert with RAB2-5 Transducer:

Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Abdominal[1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])

GE Voluson 730 Pro/Expert with RAB4-8P Transducer:

Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Abdominal[1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])

GE Voluson 730 Pro/Expert with RAB2-5L Transducer:

Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Abdominal[1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])

GE Voluson 730 Pro/Expert with RAB4-8L Transducer:

Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Abdominal[1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])

GE Voluson 730 Pro/Expert with RSP5-12 Transducer:

Pediatric: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Small Organ[2]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Intraoperative: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse
Intraoperative Neurological: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse

GE Voluson 730Pro/Expert with RIC5-9 Transducer:

Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Transrectal: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])
Transvaginal: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])

GE Voluson 730 Pro/Expert with RRE6-10 Transducer:

Transrectal: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse (Notes: [5,6])

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

Product codes (comma separated list FDA assigned to the subject device)

90 IYN, IYO, and ITX

Device Description

The Voluson 730 Pro or Expert is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 68 cm wide, 100 cm deep and 145 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color LCD/TFT display (Expert version) and a color video CRT. This modification will provide users with additional probe options, improved user interface and image enhancement.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Echo, Ultrasonic Pulsed Doppler

Anatomical Site

Fetal; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transvaginal (TV); Transrectal (TR); Intraoperative (abdominal, PV and neurological).
Specific details per transducer:
AB2-7: Fetal / Obstetrics, Abdominal, Pediatric, Musculo-skeletal Conventional
AC2-5: Fetal / Obstetrics, Abdominal
SP4-10: Pediatric, Small Organ, Peripheral Vascular, Musculo-skeletal Conventional
SP6-12: Pediatric, Small Organ, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial
SP10-16: Small Organ, Musculo-skeletal Superficial
PA2-5P: Abdominal, Adult Cephalic, Cardiac
PA6-8: Neonatal Cephalic, Adult Cephalic, Cardiac
IC5-9: Fetal / Obstetrics, Transrectal, Transvaginal
SCW2.0: Cardiac
PCW4.0: Cardiac, Peripheral Vascular
RAB2-5: Fetal / Obstetrics, Abdominal, Musculo-skeletal Conventional
RAB4-8P: Fetal / Obstetrics, Abdominal, Musculo-skeletal Conventional
RAB2-5L: Fetal / Obstetrics, Abdominal, Musculo-skeletal Conventional
RAB4-8L: Fetal / Obstetrics, Abdominal, Musculo-skeletal Conventional
RSP5-12: Pediatric, Small Organ, Peripheral Vascular, Musculo-skeletal Superficial, Intraoperative, Intraoperative Neurological
RIC5-9: Fetal / Obstetrics, Transrectal, Transvaginal
RRE6-10: Transrectal

Indicated Patient Age Range

Adult and Pediatric (for Cardiac); Pediatric and Neonatal (for small organ)

Intended User / Care Setting

Qualified physician / Not Specified

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.
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 9001 and 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 Medical Systems that the GE Voluson 730Pro/Expert BT03 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K003525

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

KQ3262D

OCT 1 0 2003

Attachment B:

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

		GE Medical Systems
		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: 414-647-4385; Fax: 414-647-4090
	Date Prepared:	August 22, 2003
2.	Device Name:	Voluson 730 Pro/Expert Diagnostic Ultrasound System, with BT03
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
	3. Marketed Device:	Voluson 730 Pro/Expert Diagnostic Ultrasound System K003525 (90-IYO/IYN)
A device currently in commercial distribution.

Device Description: The Voluson 730 Pro or Expert is a full featured general purpose diagnostic 4. ultrasound system. It consists of a mobile console approximately 68 cm wide, 100 cm deep and 145 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color LCD/TFT display (Expert version) and a color video CRT . This modification will provide users with additional probe options, improved user interface and image enhancement.

Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Orqan (breast, testes, thyroid etc.); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
Comparison with Predicate Device: The Voluson 730 Pro/Expert BT03 is of a comparable type and substantially equivalent to the current GE Voluson 730 Pro/Expert and GE LOGIQ 9. It has the same technological characteristics, key safety and effectiveness features, 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.
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 Medical Systems that the GE Voluson 730Pro/Expert BT03 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

1

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Mr. Allen Schuh Manager, Safety & Regulatory Engineering GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue MILWAUKEE WI 53219

Re: K032620

Trade Name: GE Voluson 730 Pro/Expert 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: 90 IYN, IYO, and ITX Dated: September 17, 2003 Received: September 22, 2003

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 730 Pro/Expert (BT03) Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

AB2-7
AC2-5
SP4-10

2

SP6-12
SP10-16
PA2-5P
PA6-8
IC5-9
SCW2.0
PCW4.0
RAB2-5
RAB4-8P
RAB2-5L
RAB4-8L
RSP5-12
RIC5-9
RRE6-10

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 (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.

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

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely yours.

Nancy C brogdon

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

Enclosure(s)

4

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert 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		P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	[5,6]
Pediatric	P	P	P		P	P	P	P	P	[5,6]
Small Organ[2]	P	P	P		P	P	P	P	P	[5,6]
Neonatal Cephalic	P	P	P		P	P	P	P	P	[5,6]
Adult Cephalic	P	P	P		P	P	P	P	P	[5,6]
Cardiac[3]	P	P	P	P	P	P	P	P	P	[5,6]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	[5,6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P	P	P	P	P	[5,6]
Transvaginal	P	P	P		P	P	P	P	P	[5,6]
Transuretheral
Intraoperative	P	P	P		P	P	P	P	P
Intraoperative Neurological	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 quidance of biopsy (2D/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)

Nancy C. Brogdon
Division Sign-Off

5

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with AB2-7 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	[6]
Abdominal[1]	E	E	E	E	E	E	E	E	[6]
Pediatric	E	E	E	E	E	E	E	E	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	E	E	E	E	E	E	E	E	[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

[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)

2

Nancy C. Brogdon
Division Sign-Off)

gical Devic

Prescription User (Per 21 CFR 801.109)

6

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with AC2-5 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	[6]
Abdominal(1)	E	E	E	E	E	E	E	E	E	[6]
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
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

[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)

Nancy Brogdon

of Reproductive, A and Radiological Devices 510(k) Number

7

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with SP4-10 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	P	P	P	P	P	P	P	P	[6]
Small Organ[2]	P	P	P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional	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: [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)

Nancy Brogdon
(Division Sign-Off)

of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Prescription User (Per 21 CFR 801.109)

8

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with SP6-12 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	P	P	P	P	P	P	P	P	[6]
Small Organ[2]	P	P	P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	[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)

Nancy C. Broodon

(Division Sigr Division of Reprodu and Radiological Device 510(k) Number

9

Diaqnostic Ultrasound Indications for Use Form GE Voluson 730 Pro/Expert with SP10-16 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]	P	P	P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	[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)

Nancy Brogdon

and Radiological Devic 510(k) Numb

Prescription User (Per 21 CFR 801.109)

10

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with PA2-5P 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
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	E	E	E		E	E	E	E	E
Cardiac[3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[3] Cardiac is Adult and Pediatric.

[*] 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)

Nancy C. Brogdon
(Division Sign-Off)

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

Prescription User (Per 21 CFR 801.109)

11

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with PA6-8 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]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic	P	P	P		P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac[3]	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
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.

[*] 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)

Nancy Brogdon
(Division Sign-Off)

Division of Reproduct ive. Al and Radiological Devices 510(k) Numbe

Prescription User (Per 21 CFR 801.109)

12

Diaqnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with IC5-9 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	[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	P	P	P	P	P	P	P	P	[6]
Transvaginal	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

[*] 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)

Nancy C hopdon
(Division Sign-Off)

Division of Reproductive and Radiological Devic 510(k) Number

Prescription User (Per 21 CFR 801.109)

13

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with SCW2.0 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]				P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
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)

(Division Sign-Of

Division of Reproduc and Radiological Devices 510(k) Number

14

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with PCW4.0 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]				P
Peripheral Vascular				P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
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)

Nancy C. Brogdon
(Division Sign-Off)

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

15

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with RAB2-5 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	[5,6]
Abdominal[1]	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	[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)

Nancy C. Broughton

(Division Sign-Off Division of Reproductive. Abd and Radiological Devices 510(k) Number _

16

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with RAB4-8P 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	[5,6]
Abdominal[1]	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	[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[5] 3D/4D Imaging Mode

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

[7] Includes infertility monitoring of follicle development

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

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

Nancy C. Brogdon

sion of Reproductive. Ab and Radiological Devices 510(k) Number

17

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with RAB2-5L 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	[5,6]
Abdominal[1]	N	N	N	N	N	N	N	N	[5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	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

[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)

Nancy C Hodgson
(Division Sign-Off)

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

E-15

18

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with RAB4-8L 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	[5,6]
Abdominal[1]	N	N	N	N	N	N	N	N	[5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac(3)
Peripheral Vascular
Musculo-skeletal Conventional	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

[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)

Nancy Brogdon

(Division Sign Division of Reproductive, and Radiological Device 510(k) Number

Prescription User (Per 21 CFR 801.109)

19

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with RSP5-12 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	[5,6]
Small Organ[2]	E	E	E	E	E	E	E	E	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E	E	E	E	E	E	[5,6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial	E	E	E	E	E	E	E	E	[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	E	E	E	E	E	E	E	E
Intraoperative Neurological	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, pediatic and neonatal patients [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)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reprodu Ktive. Abo and Radiological Devices 510(k) Numb

20

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730Pro/Expert with RIC5-9 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	[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	P	P	P	P	P	P	P	P	[5,6]
Transvaginal	P	P	P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[7] Includes infertility monitoring of follicle development

[*] 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)

510(k) Number

Nancy C. Brogdon

(Division Sign-Off Division of Reproductive, Abdi and Radiological Devices

Prescription User (Per 21 CFR 801.109)

Devices K632620

21

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with RRE6-10 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 / 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 | P | P | P | | P | | P | P | P | P | [5,6] |
| Transvaginal | | | | | | | | | | | |
| 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)

[*] 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)

Nancy C. Brogdon
Sign-Off:

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