Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a general-purpose diagnostic ultrasound system with standard image processing capabilities and does not mention AI, ML, or related concepts.

Therapeutic

No
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, not one that directly treats or provides therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" identifies the systems as "full featured, general purpose diagnostic ultrasound systems".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile console" with physical components like a keyboard, controls, and displays, indicating it is a hardware system with integrated software, not a software-only 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 "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that performs imaging on the human body, not a device that analyzes samples from the human body (which is the core function of an IVD).
Device Description: The description details a "mobile console" with probes that are applied to the patient for imaging. This aligns with the description of an ultrasound system used for in-vivo imaging.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components associated with in vitro diagnostic testing.

Therefore, the Voluson 730 Pro/Expert Diagnostic Ultrasound System is a medical device used for in-vivo diagnostic imaging, not 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 Organ (breast, testes, thyroid etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral (Fransredi, Myrold 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:

Fetal / Obstetrics (Includes infertility monitoring of follicle development)
Abdominal (Includes renal, GYN/Pelvic)
Pediatric
Small Organ (Includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients)
Neonatal Cephalic
Adult Cephalic
Cardiac (Adult and Pediatric)
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Transrectal
Transvaginal
Intraoperative
Intraoperative Neurological

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Includes imaging of guidance of biopsy (2D/3D/4D).
3D/4D Imaging Mode.

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

90 IYN, IYO, and ITX

Device Description

The Voluson 730 Pro/Expert are full featured, general purpose diagnostic ultrasound systems. They 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 display (Expert) and color 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

Ultrasound

Anatomical Site

Fetal; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral (Fransredi, Myrold Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).

Indicated Patient Age Range

Adult, Pediatric, Neonatal Fetal.

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): 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, K032620

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

Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K041688". The characters are written in a cursive style, with some connections between the letters. The background is plain white.

Attachment B:

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

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

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: 414-647-4385; Fax: 414-647-4090 |
| | Date Prepared: | June 18, 2004 |
| 2. | Device Name: | Voluson 730 Pro/Expert Diagnostic Ultrasound System BT04
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |

1. Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound System K003525, K032620 A device currently in commercial distribution.
  The Voluson 730 Pro/Expert are full featured, general purpose diagnostic Device Description: 4. ultrasound systems. They 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 display (Expert) and color 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 Organ (breast, testes, thyroid etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral (Fransredi, Myrold Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
Comparison with Predicate Device: The Voluson 730 Pro/Expert BT04 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.

1. 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 garantischurer 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 730Pro/Expert BT04 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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping waves or curves.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2004

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

Re: K041688

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 Regulatory Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: June 18, 2004 Received: June 24, 2004

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 mersate commerce price 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 the general softh 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 rins determinan 730 Pro/Expert Ultrasound System, as described in your premarket notification:

2

	Transducer Model Number
AB2-7
AC2-5
SP4-10
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
4C-A
RIC5-9H
IC5-9H
RNA5-9

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 it may or subject to sail as alleral 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 r louse of acrised a determination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I odetar statutes and including, but not limited to: registration and listing (21 Comply with an the Net 810 cm (21 CFR Part 801); good manufacturing practice requirements as set OF K Part 8077; accems (21 CFR Part 820); and if applicable, the electronic form in the quarty by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping rins 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 m Appendix US (encreboor ee of Diagnostic Ultrasound Systems and Transducers." If the special Becking Manteling Orcarantes 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

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.

3

Page 2 - Mr.Schuh

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please If you desire of Compliance at (301) 594-4591. Additionally, for questions on the contact the Office of Compilanov device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket 4057. Also, production and 807.97). Other general information on your responsibilities under the non 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 Brogdon

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

Enclosures

4

I

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	N	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P		P	N	P	P	P	P	[5,6]
Small Organ[2]	P	P	P		P	N	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	N	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P		P	N	P	P	P	P	[5,6]
Musculo-skeletal Superficial	P	P	P		P	N	P	P	P	P	[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P	N	P	P	P	P	[5,6]
Transvaginal	P	P	P		P	N	P	P	P	P	[5,6]
Transuretheral
Intraoperative	P	P	P		P	N	P	P	P	P
Intraoperative Neurological	P	P	P		P	N	P	P	P	P
Intravascular
l anaroscopic

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

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

[1] Hodonimal 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

[1] mondoo intender, 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. Abd and Radiological Devices 51()(k) Number _

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]	P	P	P	P	N	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	N	P	P	P	P	[6]
Pediatric	P	P	P	P	N	P	P	P	P	[6]
Small Organ(2)
Neonatal Cephalic
Adult Cephalic
Cardiac (3)
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	N	P	P	P	P	[6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
I anamsonnic

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

[1] Includes intertility morneting and 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

T

Division Sinn. Division of Reproducti and Radiological Devices 510(k) Number

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]	P	P	P	P	N	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	N	P	P	P	P	[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

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

[1] meludes intertilly monitoring 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. Thornton

Division 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	N	P	P	P	P	[6]
Small Organ[2]	P	P	P	P	N	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	N	P	P	P	P	[6]
Musculo-skeletal Conventional	P	P	P	P	N	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)

Nancyc brogdon

(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
510(k) Number K041688

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	N	P	P	P	P	[6]
Small Organ[2]	P	P	P	P	N	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	N	P	P	P	P	[6]
Musculo-skeletal Conventional	P	P	P	P	N	P	P	P	P	[6]
Musculo-skeletal Superficial	P	P	P	P	N	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

N = now indisation, , [6] Includes imaging of guidance of biopsy (2D)

[1] Combined modes are BM, 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 Reproductive, A and Radiological Devices 510(k) Number _

9

Diagnostic 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	N	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial	P	P	P	P	N	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, pediatic and neonatal patients [6] Includes imaging of guidance of biopsy (2D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Hodgson

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

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]	P	P	P	P	P	P	P	P	P	P
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
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
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.

[0] 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 Hodgdon

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

11

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with PA6-8 Transducer 1

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	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
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
1 anarosconic

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

Notes: {3} Cardiac is Adult and Pediatric.

[0] 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. Snogdon

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

12

Diagnostic 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	N	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	N	P	P	P	P	[6]
Transvaginal	P	P	P	P	N	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 Brogdon
_**_, and the text is "(Sign-Off)".

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

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)

Nancy Choydon

(Division Sian-Off Division of Reproductive. Abe 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
Iaparoscopic

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. Hogdon
(Division Sign-Off)

Division of Reproductive, Abdo 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	N	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	N	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	N	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

[1] Combined modes are BM, 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-C Division of Reproductive. Ab 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 / Obstetrics71	P	P	P	P	N	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	N	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	N	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 (ODE)

Nancy C Hodgson

(Division S Division of Reproductive. 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]	P	P	P	P	N	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	N	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	N	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 BM, 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. broydon

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

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]	P	P	P	P	P	N	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	P	N	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	N	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

[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)

Nancy C. Hogdon

(Division Sign-Off Abdom Dansion of Reproductiv ··· Dadiological Devices angky Bumber

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

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

N = new Malouton, + = provided breast, testes, thyroid, salivary gland, lymph nodes, pediatio 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 Brogdon
(Division Sign-Off)

Division of Reproductive. Abdo and Radiological Devices 519(k) Number

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	N	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	N	P	P	P	P	[5,6]
Transvaginal	P	P	P	P	N	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)

Nency Snogdon
(Division Sign-Off)

Division of Reproductive. Abd and Radiological Devices 517(k) Number

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:

	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	P	P	P	P	N	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. Hogdon
(Division Sign-Off)

Division of Reproductive. Abdor and Radiological Devices 510(k) Number _

22

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with 4C-A 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	[6]
Abdominal[1]	N	N	N	N	N	N	N	N	N	[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	[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

[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)

and Radiological Devices

510(k) Number __

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

23

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730Pro/Expert with RIC5-9H 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]
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	N	N	N	N	N	N	N	N	N	[5,6]
Transvaginal	N	N	N	N	N	N	N	N	N	[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

[1] Combined modes are BM, 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)

Nancyc Hogdon
(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological Devices 510(k) Number __ _____________________________________________________________________________________________________________________________________________________________

24

Diagnostic Ultrasound Indications for Use Form

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

[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)

Nancy Chozdon

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

25

Diagnostic Ultrasound Indications for Use Form

GE Voluson 730 Pro/Expert with RNA5-9 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]
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]	N	N	N	N	N	N	N	N	N	[5,6]
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	[5]
Adult Cephalic
Cardiac (3)	N	N	N	N	N	N	N	N	N	[5]
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
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 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)

[0] morados integring or group.
[1] Combined modes are BM, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

51000 Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nano
ro
(Division Sign-Off)
Division of Reproductive, Abdominal,
ani Radiological Devices 111