# K071985: GE Vivid S5 and S6 Diagnostic Ultrasound

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Aug 17, 2007 after 29 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000695 (2000). 2 ancestors in all.
412 later devices descend from it; 2 cite it directly.
0 of 415 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020789: GE Vivid 3 Expert; GE Vivid 3 Pro, General Electric Co. (2002) Summary page 1.

## Most influential descendants
- K092079: Modification to GE Vivid S5 and S6 Diagnostic Ultrasound (2009), 331 descendants of its own
- K102388: Vivid I Diagnostic Ultrasound System (2010), 284 descendants of its own
- K120201: GE Vivid E9 Diagnostic Ultrasound Imaging System (2012), 253 descendants of its own
- K102393: Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System (2010), 177 descendants of its own
- K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System (2012), 176 descendants of its own

## Recalls of this device
- Nov 10, 2022 · Class II · Z-0752-2023: Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
- Nov 10, 2022 · Class II · Z-0753-2023: Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; 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).

Source page: https://510kreport.com/device/K071985
Methodology: https://510kreport.com/methodology