GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
Device Facts
| Record ID | K032620 |
|---|---|
| Device Name | GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM |
| Applicant | General Electric Co. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 10, 2003 |
| 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 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).
Device Story
Voluson 730 Pro/Expert is a mobile diagnostic ultrasound system for digital acquisition, processing, and display of ultrasound images. It utilizes a console with keyboard, specialized controls, and display (LCD/TFT or CRT). The system processes ultrasonic pulsed echo and Doppler signals to generate images for clinical evaluation. It supports various transducers for applications including fetal, abdominal, cardiac, and musculoskeletal imaging. Used in clinical settings by physicians to perform diagnostic exams and biopsy guidance. The system provides real-time visualization, aiding in clinical decision-making for patient diagnosis and monitoring. Benefits include non-invasive diagnostic assessment across multiple anatomical regions.
Clinical Evidence
No clinical data required. Substantial equivalence is supported by non-clinical testing, including acoustic output measurements, biocompatibility, and thermal/electrical/mechanical safety testing, confirming conformance to established medical device safety standards.
Technological Characteristics
Mobile console (68x100x145 cm) with digital acquisition/processing. Supports multiple transducers (e.g., AB2-7, AC2-5, SP4-10). Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, Harmonic, Coded Pulse, 3D/4D. Conforms to 21 CFR 892.1550/1560/1570. Quality systems: 21 CFR 820, ISO 9001, ISO 13485.
Indications for Use
Indicated for ultrasound evaluation of fetal, abdominal, GYN, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transvaginal, transrectal, and intraoperative applications. Used by qualified physicians for diagnostic imaging and fluid flow analysis.
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
- Voluson 730 Pro/Expert Diagnostic Ultrasound System (K003525)
- GE LOGIQ 9
Related Devices
- K041688 — GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 · General Electric Co. · Jul 8, 2004
- K122327 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Sep 21, 2012
- K103649 — VOLUSON S6, VOLUSON S8 · GE Healthcare · Mar 9, 2011
- K131267 — VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 · GE Healthcare · Jun 19, 2013
- K122387 — VOLUSON P6, VOLUSON P8 · GE Healthcare · Sep 11, 2012
Submission Summary (Full Text)
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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<br>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: | August 22, 2003 | |
| 2. | Device Name: | Voluson 730 Pro/Expert Diagnostic Ultrasound System, with BT03<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 (90-IYO/IYN)<br>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.
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 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).
6. 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):
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 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.
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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<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 | | 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<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] | 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<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) | 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<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 | | 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<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 | | 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<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 | | 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<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] | 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<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 | | |
| 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<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 | | 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<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)
> > (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<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] | | | | | | | | |…
