# K092079: Modification to GE Vivid S5 and S6 Diagnostic Ultrasound

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Israel, Ultrasound, Ltd.
- Decided: Aug 6, 2009 after 28 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: 3 generations back to K000695 (2000). 3 ancestors in all.
331 later devices descend from it; 4 cite it directly.
0 of 335 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071985: GE Vivid S5 and S6 Diagnostic Ultrasound, General Electric Co. (2007) Summary page 1.

## Most influential descendants
- 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
- K101324: GE Echopac Model BT10 (2010), 172 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
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ultrasound imaging, measurement and analysis of the human body as follows:

Source page: https://510kreport.com/device/K092079
Methodology: https://510kreport.com/methodology