# K234106: Venue Fit

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jun 10, 2024 after 167 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: 27 generations back to K935595 (1995). 200 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220848: Venue Fit, GE Medical Systems (2022) Summary page 4.

## Most influential descendants
- K251322: Venue; Venue Go; Venue Fit; Venue Sprint (2025), 1 descendant of its own
- K261668: Venue Go (2026), 0 descendants of its own

## Recalls of this device
- Mar 6, 2025 · Class II · Z-1556-2025: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

## Indications for use
The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Source page: https://510kreport.com/device/K234106
Methodology: https://510kreport.com/methodology