# K020789: GE Vivid 3 Expert; GE Vivid 3 Pro

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Apr 4, 2002 after 24 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000695 (2000). 1 ancestor in all.
487 later devices descend from it; 4 cite it directly.
0 of 489 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000695: GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging System, Ge Medical Systems, Inc. (2000)

## Most influential descendants
- K071985: GE Vivid S5 and S6 Diagnostic Ultrasound (2007), 412 descendants of its own
- K033139: GE Marlin Ultrasound (2003), 350 descendants of its own
- K061525: GE Vivid - I (2006), 349 descendants of its own
- K092079: Modification to GE Vivid S5 and S6 Diagnostic Ultrasound (2009), 331 descendants of its own
- K082374: Vivid I and Vivid Q (2008), 286 descendants of its own

## Indications for use
The GE Vivid 3 Expert/Pro systems are general purpose ultrasound systems that are specialized for cardiac imaging. Specific clinical uses include cardiac (adult & pediatric); peripheral vascular; transesophageal; abdominal including GYN and urology; fetal; pediatric; small organ including breast, testes, thyroid; adult and neonatal cephalic; intraoperative (abdominal, thoracic, and vascular); musculo-skeletal (conventional and superficial); transvaginal and transrectal.

Source page: https://510kreport.com/device/K020789
Methodology: https://510kreport.com/methodology