# K152758: Venue 50

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Nov 18, 2015 after 55 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: 18 generations back to K935595 (1995). 138 ancestors in all.
55 later devices descend from it; 2 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133431: VENUE 50, GE Healthcare (2013) Summary page 4.
- K142443: Site-Rite 6 Ultrasound System with Pinpoint GT Technology, C.R. Bard, Inc. (2014) Summary page 12.

## Most influential descendants
- 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
- K183362: Venue GO (2019), 14 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. When Pinpoint GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Source page: https://510kreport.com/device/K152758
Methodology: https://510kreport.com/methodology