# K061525: GE Vivid - I

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Jul 3, 2006 after 31 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (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.
349 later devices descend from it; 3 cite it directly.
0 of 353 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033139: GE Marlin Ultrasound, General Electric Co. (2003) Summary page 1.

## Most influential descendants
- K082374: Vivid I and Vivid Q (2008), 286 descendants of its own
- K092140: GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound (2009), 285 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
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System (2013), 167 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.

## 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). Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K061525
Methodology: https://510kreport.com/methodology