# K102388: Vivid I Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical System Israel, Ltd.
- Decided: Nov 4, 2010 after 73 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: 6 generations back to K000695 (2000). 8 ancestors in all.
284 later devices descend from it; 3 cite it directly.
0 of 293 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092140: GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound, Ge Medical Systems Israel, Ultrasound, Ltd. (2009) Summary page 2.
- K092079: Modification to GE Vivid S5 and S6 Diagnostic Ultrasound, Ge Medical Systems Israel, Ultrasound, Ltd. (2009) Summary page 2.

## Most influential descendants
- K120201: GE Vivid E9 Diagnostic Ultrasound Imaging System (2012), 253 descendants of its own
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System (2013), 167 descendants of its own
- K121062: Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System (2012), 110 descendants of its own
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2015), 100 descendants of its own
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems (2013), 96 descendants of its own

## Recalls of this device
- Nov 10, 2022 · Class II · Z-0756-2023: 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-0757-2023: 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 current modifications do not change the indications for use. As previously reported and cleared, the Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.

Source page: https://510kreport.com/device/K102388
Methodology: https://510kreport.com/methodology