# K221148: Vivid iq

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decided: Jul 18, 2022 after 89 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: 26 generations back to K935595 (1995). 275 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 278 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200708: Vivid iq, Ge Medical Systems Ultrasound And (2020) Summary page 4.

## Most influential descendants
- K250913: TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (2025), 0 descendants of its own
- K243620: Vivid iq (2025), 0 descendants of its own

## Indications for use
The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. It is intended for use by Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.

Source page: https://510kreport.com/device/K221148
Methodology: https://510kreport.com/methodology