GE VOLUSON I
Device Facts
| Record ID | K053435 |
|---|---|
| Device Name | GE VOLUSON I |
| Applicant | General Electric Co. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 16, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follice development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
Device Story
Voluson i is a compact, portable, notebook-style diagnostic ultrasound system. It acquires, processes, and displays ultrasonic pulsed echo and Doppler signals to provide real-time imaging. Operated by qualified physicians in clinical settings, the device supports various modes including B, M, PW/CW Doppler, Color/Power Doppler, and 3D/4D imaging. It utilizes interchangeable transducers to perform exams across multiple anatomical regions. The system provides visual output on an integrated display, assisting clinicians in diagnostic evaluations, biopsy guidance, and monitoring of physiological states like follicle development. The portable design enhances convenience for point-of-care or clinical use.
Clinical Evidence
No clinical data required. Device safety and effectiveness were established through non-clinical bench testing, including acoustic output measurements, biocompatibility, and electrical safety testing, confirming conformance with applicable standards.
Technological Characteristics
Portable notebook-style ultrasound system. Supports B, M, PW/CW Doppler, Color/Power Doppler, and 3D/4D imaging modes. Compatible with multiple RS-series transducers. Conforms to 21 CFR 892.1550, 892.1560, and 892.1570. Operates via ultrasonic pulsed echo and Doppler principles. Manufactured under ISO 13485 quality systems.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transvaginal, transrectal, and intraoperative applications.
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
Submission Summary (Full Text)
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DEC 16 2005
ko 53435
#### Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circular border, creating a recognizable emblem for the company.
#### 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: | December 8, 2005 |
| 2. Device Name: | Voluson i Diagnostic Ultrasound System<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
3. Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound - K003525, K032620, K041688 A device currently in commercial distribution.
4. Device Description: The Voluson i is a compact, general purpose diagnostic ultrasound system which 4. Device Describited. The Voluson is a sense , goride, 313 mm deep and 59 mm high when closed. consists of a portable consolitically oo min the your a notebook-like user interface consisting of It has agailal acquisition, processing and display ou a notification will provide users with enhanced convenience and portability.
5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follice development); Pediatric of Feial/OB, Abdominal (Including OTN, pervice and Internation (adult and pediatio);
Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; (TV); Transport Strail Organ (preast, testes, thyrou ctc.), reonatur and Paul. So, Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
6. Comparison with Predicate Devices: With respect to features and applications, the Voluson is of a o. Quilibalison will i redicate Dovisor white the unmodified Voluson 730 Pro/Expert and also to the comparable type and substantially oqurtail.com the same technological characteristics, key safety and effectiveness features, and similar physical design, construction, and materials.
#### Section b):
1. Non-dinical Tests: The device has been evaluated for acoustic output, biocompatibility, beaning and 1. Northallincal rests. The dovice has book of accommission 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 traditor. I reactive, FDA 5. Outligusion. Thich could one ney to reasonation. The design and development process of the davine sesferms gudelines, and established include of pation one in 14485 quality systems. The device conforms manufacturer conforms with 21 OF C 88, 100 connent is verified through independent evaluations of esfa and to applicable inedical device sales and compulated a long history of safe and with origoing factory survellance. "Diagnoons and of GE Healthcare that the GE Volusor i Diagnostic effective performatice. Therefore, it is the opinion of O2 readined in the evices currently cleared for market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The seal is black and white.
DEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K053435
Trade Name: GE Voluson i Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 8, 2005 Received: December 9, 2005
Dear Mr. Schuh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premaintentially equivelent (for the referenced above and we have determined the device marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predicel Davice interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate collineree prof to May 20, 1978, the case with the provisions of the provisions of the subject to Amendments, or to devices market Act (Act). You may, therefore, market the device, subject to Federal Food, Drug, and Cosment Processor (Free). Founday someral controls provisions of the Actinclude the general controls provisions of the Feir - No Fees, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intential I his determination of substantar equirated upposes in the many of emarket notification:
Transducer Model Number
12L-RS PA2-5-RS
{2}------------------------------------------------
E8C-RS
RAB2-5-RS
RSP6-16-RS
RIC5-9-RS
4C-RS
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sce above) into e. Existing major regulations affecting your device. FDA it may be subject to such addinonal controls: "Existing highert good to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to Associa can be found in the Code of I cucial Regulations, Fried in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ Issualles of a sudomatic equirements of the Act
that FDA has made a determination that your device only addres accepains. You must that FDA has made a decermination and your and your her Federal agencies. You must or any Federal statures and regulations administered of registration and listing (21
comply with all the Act's requirements, including, but not was requirements as set comply with all the Act S requirements, monation ing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the electronic CFR Part 807); labeling (21 CFR Fart 800); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (21-51-542 of the Act); 21 CFR 1000-1050.
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 print online in This determination of Substantial equivalence special report should contain complete the first device, you submit a postcreatine special reported on production line devices, requested
information, including acoustic output measurements based on production for information, including acousus output measurements 30, 1997 "Information for Manufacturers" in Appendix G, (enclosed) of the Center S September 30, 1977 - and Transducers." If the special Seeking Marketing Clearance of Diagnostic United Co., acoustic output greater than approved report is incomplete of contails unaccepable varies (orgi, doction in the 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 The special report should reference the manufactures in duplicate to:
> Food and Drug Administration i 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 I his letter will anow you to begin marketing your device of your device to a legally marketed notification. The PDA imania of succeantal required and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your ac not on one on one one the regulation entitled, contact the Office of Comphance at (210) 275 -ation" (21CFR Part 807.97). You may obtain " Misbranding by reference to premarket notification - (2) OF C S C from the Division of Small
{3}------------------------------------------------
Page 3 – Mr. Schuh
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collisuner Assistance at to ter levels.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact REVIEWER 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)
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### Diagnostic Ultrasound Indications for Use Form
#### GE Voluson i 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 | P | [5,6] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [5,6] |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | [5] |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | [5] |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [5,6] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | | P | P | P | P | P | P | |
| Intraoperative Neurological | P | P | P | | P | P | P | P | P | P | |
| Intravascular | | | | | | | | | | | |
| | | | | | | | | | | | |
| Labarsopic
N = new indication: P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[1] Abdonimal includes renar, OTNF owle
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients [3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (2D/3D/4D)
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[8] Includes urologyprostate
[*] 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)
Pivision of Reproductive, Abdominal ୍ୟ Radiological Devices 5 ! O(k) Number _
E-2
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..............................................................................................................................................................................
# Diagnostic Ultrasound Indications for Use Form
# GE Voluson i with 12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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] | | | | | N | N | N | N | N | N | [6] |
| Pediatric | N | N | N | | N | N | N | N | N | N | [6] |
| Small Organ[2] | N | N | N | | N | N | N | N | N | N | [6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | N | N | N | [6] |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | N | N | N | [6] |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | N | N | N | [6] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | N | N | N | | N | N | N | N | N | N | |
| Intraoperative Neurological | N | N | N | | N | N | N | N | N | N | |
| Intravascular | | | | | | | | | | | |
Laparoscopic ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
N = new indication; P = previously deared by FDA; E = added under Appellux E
Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric
[6] Includes imaging of guidance of biopsy (2D)
[6] Includes imaging of guidance of blopsy (2D)
{"] Combined modes are B/M, B/Color M, B/PWD or CWD, B/ColoriPWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) SEDONOTWRITEDECOM Office of Device Evaluation (ODE)
Daney C. Brogdon
(Division Sign-Off)
T
Division of Reproductive, Abdominal ano Radiological Devices 5 ! (k) Number ______________
{6}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
## GE Voluson i with PA2-5-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | P | |
| Cardiac [3] | P | 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 | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
Labalosopio
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.
[3] Cardiac is Adult and Pealativ.
[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 Eva!nation (ODE)
Nancy C. Hogdon
(Division Sign-Off)
arren at Rearchin and Carrological Devic 510(k) Number
{7}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
## GE Voluson i with E8C-RS 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] | N | N | N | | N | N | N | N | N | N | [6] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | | N | N | N | N | N | N | |
| 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 | | | | | | | | | | | |
Notes: [6] Includes imaging of guidance of biopsy (2D)
[7] Includes infertility monitoring of follicle development
[/ Includes internity montoning of follolo dovelopment
["] 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
โ
(Division Sig Division of Reproduc ive Abdo and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{8}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
## GE Voluson i with RAB2-5-RS 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 | P | [5,6] |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
Labaroscopic
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] Includes imerally monitoring or relations of tellists of the Province 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 C. Brogdon
of Reproci VA. Ab and Particlogical Devices (k) Number _
{9}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
# GE Voluson i with RSP6-16-RS 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 | E | E | E | | E | E | E | E | E | E | [5,6] |
| Small Organ[2] | E | E | E | | E | E | E | E | E | E | [5,6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | E | E | E | [5,6] |
| Musculo-skeletal Conventional | E | E | E | | E | E | E | E | E | E | [5,6] |
| Musculo-skeletal Superficial | E | E | E | | E | E | E | E | E | E | [5,6] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | E | E | E | | E | E | E | E | E | E | |
| Intraoperative Neurological | E | E | E | | E | E | E | E | E | E | |
| Intravascular | | | | | | | | | | | |
| Capansopic
N = newindication; P = previously cleared by FDA; E = added under Appendix E
N = new indication; P = previously dealed by PDA, E = added ander Apportan =
Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediati [5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[7] Includes infertility monitoring of follicle development
[ ] Includes internity monioning of folliele Gevelopment
[ ] 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, and Radiological Devices 510(k) Number _
{10}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
## GE Voluson i with RIC5-9-RS 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 | P | [5,6] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
- Expares --------------------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: [5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[6] Includes 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 Division of Reproductive, Ab forninal, and Radiological Devices - Number _
{11}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
## GE Voluson i with 4C-RS Transducer
T
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 | P | P | [6] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [6] |
| Pediatric | N | N | N | N | N | N | N | N | N | N | [6] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [6] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| | | | | | | | | | | | |
Labarssopic
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 intertify montaining er comise 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. Boydon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 5 : (k) Number _
