# K202132: Venue

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Nov 13, 2020 after 105 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: 24 generations back to K935595 (1995). 196 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180599: Venue, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 4.

## Most influential descendants
- K220851: Venue (2022), 3 descendants of its own
- K240111: Venue (2024), 2 descendants of its own
- K220940: EchoPAC Software Only, EchoPAC Plug-in (2022), 2 descendants of its own
- K251322: Venue; Venue Go; Venue Fit; Venue Sprint (2025), 1 descendant of its own
- K251342: EchoPAC Software Only / EchoPAC Plug-in (2025), 1 descendant of its own

## Indications for use
The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue is intended to be used in a hospital or medical clinic. Venue 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/K202132
Methodology: https://510kreport.com/methodology