# K251322: Venue; Venue Go; Venue Fit; Venue Sprint

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jul 25, 2025 after 87 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: 28 generations back to K935595 (1995). 208 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240111: Venue, GE Medical Systems Ultrasound and Primary Care Diagnostics (2024) Summary page 5.
- K240053: Venue Go, GE Medical Systems Ultrasound and Primary Care Diagnostics (2024) Summary page 5.
- K234106: Venue Fit, GE Medical Systems Ultrasound and Primary Care Diagnostics (2024) Summary page 5.
- K240206: Venue Sprint, GE Medical Systems Ultrasound and Primary Care Diagnostics (2024) Summary page 5.

## Most influential descendants
- K261668: Venue Go (2026), 0 descendants of its own

## Indications for use
The Venue, Venue Go, Venue Fit and Venue Sprint are general purpose diagnostic ultrasound systems 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, Venue Go and Venue Fit are intended to be used in a hospital or medical clinic. Venue, Venue Go and 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. The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance. Venue Sprint 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, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.

Source page: https://510kreport.com/device/K251322
Methodology: https://510kreport.com/methodology