GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
Device Facts
| Record ID | K041688 |
|---|---|
| Device Name | GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 |
| Applicant | General Electric Co. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 8, 2004 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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 (Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
Device Story
Voluson 730 Pro/Expert BT04 is a mobile, full-featured diagnostic ultrasound system. It acquires, processes, and displays digital ultrasound data using various modes (B, M, PW/CW Doppler, Color/Power Doppler, Harmonic, 3D/4D). Operated by qualified physicians in clinical settings, the system utilizes a console with keyboard, specialized controls, and color display. It processes acoustic echoes to generate real-time images for anatomical evaluation and fluid flow analysis. Output assists clinicians in diagnosis, biopsy guidance, and monitoring (e.g., follicle development). Benefits include non-invasive visualization of internal structures and blood flow, aiding clinical decision-making across diverse patient populations.
Clinical Evidence
No clinical data required. Substantial equivalence is supported by non-clinical testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with applicable standards.
Technological Characteristics
Mobile console (68x100x145 cm) with digital acquisition/processing. Includes color LCD/CRT displays. Supports multiple transducers (e.g., AB2-7, RAB2-5, RIC5-9). Modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D. Conforms to 21 CFR 820, ISO 9001, ISO 13485. Connectivity includes digital display and interface controls.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, GYN, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, and musculoskeletal applications. Includes transvaginal, transrectal, and intraoperative access. Used for biopsy guidance and infertility monitoring.
Regulatory Classification
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.
Predicate Devices
Related Devices
- K032620 — GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM · General Electric Co. · Oct 10, 2003
- K113758 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Jan 10, 2012
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
- K120741 — VOLUSON S6, VOLUSON S8 · GE Healthcare · Apr 27, 2012
- K201462 — ACUSON Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jun 24, 2020
Submission Summary (Full Text)
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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<br>PO Box 414<br>Milwaukee, WI 53201 |
|----|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Allen Schuh,<br>Manager, Safety and Regulatory Engineering<br>Telephone: 414-647-4385; Fax: 414-647-4090 |
| | Date Prepared: | June 18, 2004 |
| 2. | Device Name: | Voluson 730 Pro/Expert Diagnostic Ultrasound System BT04<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |
- 3. 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.
5. 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).
6. 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):
1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
- 2. Clinical Tests: None required.
3. 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.
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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:
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| | Transducer Model Number | |
|------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| AB2-7<br>AC2-5<br>SP4-10<br>SP6-12<br>SP10-16<br>PA2-5P<br>PA6-8 | IC5-9<br>SCW2.0<br>PCW4.0<br>RAB2-5<br>RAB4-8P<br>RAB2-5L<br>RAB4-8L | RSP5-12<br>RIC5-9<br>RRE6-10<br>4C-A<br>RIC5-9H<br>IC5-9H<br>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.
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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
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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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(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 _
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### 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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | |
| Abdominal[1] | | | | |…
