VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM
Device Facts
| Record ID | K102393 |
|---|---|
| Device Name | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM |
| Applicant | Ge Medical System Israel , Ltd. |
| Product Code | IYO · Radiology |
| Decision Date | Nov 5, 2010 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Device Story
Vivid S5/S6 are mobile ultrasound consoles using electronic array transducers for echocardiography, vascular, and general imaging. Device captures acoustic signals, processes them via internal software, and displays real-time images/measurements for clinician review. Features include auto-optimization, compact size, and maneuverability. Operated by physicians or under their direction in clinical settings. Output assists in diagnostic evaluation and clinical decision-making. Benefits include efficient, high-quality imaging for diverse anatomical regions and patient populations.
Clinical Evidence
No clinical studies required. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing.
Technological Characteristics
Mobile ultrasound console; electronic array transducers; B, M, PW/CW/Color/Power Doppler, Color M, Harmonic Imaging, Coded Pulse modes. Biocompatible patient-contact materials. Conforms to medical device safety standards for electrical, thermal, and electromagnetic safety. Software-based image processing.
Indications for Use
Indicated for ultrasound imaging and analysis in fetal/obstetrics, abdominal/GYN, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urology (including prostate), transesophageal, transrectal, transvaginal, and intraoperative (abdominal, thoracic, vascular) applications. Prescription use only.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems (K092079)
Reference Devices
- Vivid S5/S6 (K071985)
Submission Summary (Full Text)
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NOV - 5 2010 K102393
# Section 5 — 510(k) Summary
Vivid S5/S6
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510(k) Premarket Notification Submission Vivid S5/S6 Ultrasound System August 18, 2010
# 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 18 August 2010 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare [GE Medical Systems Ultrasound and Primary Care<br>Diagnostics, LLC]<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare, [GE Medical Systems Ultrasound and Primary Care<br>Diagnostics, LLC]<br>T:(414)721-4214<br>F:(414)918-8275<br>GE Healthcare |
| Secondary Contact Person: | Jim Turner<br>Regulatory Affairs Manager America's Service<br>GE Healthcare, [GE Medical Systems Ultrasound and Primary Care<br>Diagnostics, LLC]<br>T:(262) 544-3359<br>F:(414)908-9225 |
| Device: Trade Name: | Vivid S5 and Vivid S6 Diagnostic Ultrasound System |
| Common/Usual Name: | Vivid S5, Vivid S6 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K092079<br>currently in commercial distribution. |
| Device Description: | The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide<br>assortment of electronic array transducers intended primarily for echocar-<br>diography with additional capability in vascular and general ultrasound<br>imaging. Its intuitive user interface, high level of auto-optimization along<br>with significantly reduced size and weight make it readily maneuverable,<br>efficient and easy to use. |
| Intended Use: | The device is intended for use by a qualified physician for ultrasound<br>evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric;<br>Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult<br>Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Mus-<br>culo-skeletal Conventional and Superficial; Urology (including pros-<br>tate); Transesophageal; Transrectal; Transvaginal; and Intraoperative<br>(abdominal, thoracic, and vascular). |
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Technology: The modified Vivid S5/S6 employs the same fundamental scientific technology as its predicate devices.
> Comparison with the predicate device shows the modified Vivid S5/ S6 is of a comparable type and substantially equivalent to the current Vivid S5/S6. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device. The modified Vivid S5/S6 has additional software features that are similar to other cleared GE Ultrasound systems. Summary of Non-Clinical Tests:
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The modified Vivid S5/S6 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) ●
- Integration testing (System verification) .
- Final Acceptance Testing (Validation) .
- . Performance testing (Verification)
- Safety testing (Verification) .
Transducer materials and other patient contact materials are biocompatible.
### Summary of Clinical Tests:
The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence.
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GE Healthcare considers the modified Vivid S5/S6 to be as safe, and Conclusion: effective as the predicate device(s). The performance of the modified Vivid S5/S6 is substantially equivalent to the predicate device(s).
> 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, and ISO13485 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 Vivid S5/S6 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226
NOV - 5 2010
Re: K102393
Trade/Device Name: Vivid S5 and Vivid S6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II . Product Code: IYN, IYO, and ITX Dated: October 4, 2010 Received: October 5, 2010
Dear Mr. Behn:
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 Vivid S5 and Vivid S6 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
6Tc/6Tc-RS 6T/6T-RS 9T/9T-RS 6T-RS
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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 895. 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 (QS) 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jana Delfino at (301) 796-6503.
Sincerely yours,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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1102393
NOV - 5 2010
510(k) Number (if known):
Device Name: Vivid S5/S6
Indications for Use:
The current modifications do not change the indications for use. As previously reported and cleared, the Vivid S5/S6 ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Prescription Use___X_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K102393
Page 1 of 1
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# Diagnostic Ultrasound Indications for Use Form
# GE Vivid S5/S6 Diagnostic Ultrasound System
Intended Use: Ultrasound imaging, measurement and 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 | | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | P | | |
| Fetal/Obstetrics | P | P | P | P | P | P | P | P | P | P | P | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ (specify)[2] | P | P | P | P | P | P | P | P | P | P | P | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | | |
| 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 | P | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | P | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | P | | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | P | | |
| Transuretheral | | | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | P | P | P | P | P | P | P | P | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E
Notes:
- [1] Abdominal includes GYN/Pelvic and Renal.
- [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology.
(Division Sign-Off)
Cardiac is Adult and Pediatric.
Other use includes Urology.
[4] Other use includes Urology.
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M
[+] Coded Pulse is for digitally encoded harmonics ..
[♥] Coded Pulse is for digitally encoded harmonics..
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
510K
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Confidential and Privileged. This document confidential and privileged trade secrets and other information of Creters Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved.
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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the border of the circle are white, while the background inside the circle is black.
(Division Sign-Off) Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510k
#### Diagnostic Ultrasound Indications for Use Form
#### GE Vivid S5/S6 with 6Tc/6Tc-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 | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac(3) | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
P = previously cleared by FDA; (Transducer previously cleared on Vivid S5/S6 (K092079));
E = added under Appendix E
Notes:
N
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[+] Coded Pulse is for digitally encoded harmonics.
[**] 6Tc-RS is cleared on Vivid S5/S6 BT10 (K092079). 6Tc differs from 6Tc-RS only in the connector type
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Elective Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved.
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Image /page/9/Picture/0 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.
# Diagnostic Ultrasound Indications for Use Form
#### GE Vivid S5/S6 with 6T/ 6T-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 | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac <sup>[3]</sup> | P | P | P | P | P | P | P | P | P | P | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | | |
| Other <sup>[4]</sup> | | | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | | |
| Intraoperative (specify) <sup>[5]</sup> | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (Transducer previously cleared on Vivid \$6 (167 1985);
E = added under Appendix E
Notes:
(Division Sign-Off)
Division of Radiological Devices
[3] Cardiac is Adult and Pediatric. *) Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
· ] Coded Pulse is for digitally encoded harmonics.
*] Due to a Typo, probe 6T was not listed in this form's heading in K071985. The probets mich
S5/S6 K071985 (see Table 2.3.3 - Transducer Characteristics Summary and Special Report)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Confidential and Privileged. This document contidential and privileged rode secrets and other information of Ceneral Elective Co. and or such may not be disclosed to others not employed by General Electric Co. All rights reserved.
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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.
GE Healthcare 510(k) Premarket Notification Submission Vivid S5/S6 Ultrasound System August 18, 2010
## Diagnostic Ultrasound Indications for Use Form
## GE Vivid S5/S6 with 9T/ 9T-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 |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
E = added under Appendix E
Notes:
(Division Sign-Off)
ision of Radiological Devices
Diagnostic Devices Branch
[3] Cardiac is Adult and Pediatric.
- ተ. ነው። የጥንተ፡ንጥ Diagnostic Device Evaluation and Safety [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[�] Coded Pulse is for digitally encoded harmonics.
[**] Due to a Typo, probe 6T was not listed in this form's heading in K071985. The probe is included in. \$5/\$6 K071985 (see Table 2.3.3 - Transducer Characteristics Summary and Special Report)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Confidential and Privileged. This document contidential and privileged rede secrets and other information of General Elective Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved.
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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate.
# Diagnostic Ultrasound Indications for Use Form
# Vivid S5/S6 -with 6T-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 | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA, (Transducer previously cleared on Vivid S5/26 (K071985); E = added under Appendix E
Notes:
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
[3] Cardiac is Adult and Pediatric. [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M
[+]Coded Pulse is for digitally encoded harmonics.
(4) Coded Pulse is for digitaly encoded harmonics.
[** Due to a Type, probe 9T was not listed in this form's heading in K071985. The probee in viving S5/S6 K071985 (see Table 2.3.3 - Transducer Characteristics Summary and Special Report)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
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