# K133431: VENUE 50

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Dec 24, 2013 after 46 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: 17 generations back to K935595 (1995). 130 ancestors in all.
60 later devices descend from it; 2 cite it directly.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112122: VENUE 40, GE Healthcare (2011) Summary page 14.
- K113156: Sonosite Edge Ultrasound System, Sonosite,Inc. (2011) Summary page 2.
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011) Summary page 2.
- K131527: Logiq S8, GE Healthcare (2013) Summary page 2.

## Most influential descendants
- K152758: Venue 50 (2015), 55 descendants of its own
- K160277: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 (2016), 47 descendants of its own
- K161706: Vivid iq (2016), 46 descendants of its own
- K170714: Venue (2017), 35 descendants of its own
- K180599: Venue (2018), 28 descendants of its own

## Indications for use
The Venue 50 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

Source page: https://510kreport.com/device/K133431
Methodology: https://510kreport.com/methodology