# K180599: Venue

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: May 2, 2018 after 56 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: 23 generations back to K935595 (1995). 195 ancestors in all.
28 later devices descend from it; 5 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170714: Venue, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2017) Summary page 5.
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 14.
- K161706: Vivid iq, Ge Medical Systems Ultrasound and Primary Care Diagnostics L (2016) Summary page 5.
- K163596: LOGIQ P9 and LOGIQ P7, GE Healthcare (2017) Summary page 5.

## Most influential descendants
- K183362: Venue GO (2019), 14 descendants of its own
- K181727: Vivid iq (2018), 9 descendants of its own
- K202132: Venue (2020), 7 descendants of its own
- K203137: Venue Fit (2020), 5 descendants of its own
- K220848: Venue Fit (2022), 4 descendants of its own

## Indications for use
The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of-care areas in offices, clinical and hospital settings for diagnosis of patients. The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).

Source page: https://510kreport.com/device/K180599
Methodology: https://510kreport.com/methodology