# K031663: GE Vivid 7, Model FC0003XX

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Jun 9, 2003 after 11 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 K003931 (2001). 1 ancestor in all.
1,003 later devices descend from it; 6 cite it directly.
2 of 1,005 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003931: Vivid 7 with Sonopac, Model FB0008XX, Ge Medical Systems, Inc. (2001)

## Most influential descendants
- K041552: GE Vivid 7 BT04 (2004), 996 descendants of its own
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 descendants of its own
- K063085: Modification to Acuson Sequoia Ultrasound System (2006), 838 descendants of its own
- K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer (2005), 806 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Source page: https://510kreport.com/device/K031663
Methodology: https://510kreport.com/methodology