# K183362: Venue GO

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jan 28, 2019 after 55 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K935595 (1995). 197 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 212 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 6.
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 6.
- K181783: Logiq P9; Logiq P7, GE Healthcare (2018) Summary page 6.

## Most influential descendants
- K203137: Venue Fit (2020), 5 descendants of its own
- K220848: Venue Fit (2022), 4 descendants of its own
- K202233: Venue Go (2020), 4 descendants of its own
- K220800: Venue Go (2022), 3 descendants of its own
- K191792: Versana Balance (2019), 3 descendants of its own

## Recalls of this device
- Mar 6, 2025 · Class II · Z-1555-2025: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
- Sep 6, 2023 · Class II · Z-2652-2023: Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.

## Indications for use
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals for ultrasound imaging, measurement and analysis of the human body and fluid. Venue Go clinical applications include the following: Abdominal (including Gynecology and Urology), Thoracic/Pleural, Ophthalmic, Fetal/Obstetrics, Small Organ (including breast, testes, thyroid), Peripheral vascular, Adult and neonatal cephalic, Pediatric, Musculoskeletal (Conventional and Superficial), Cardiac (Adults and Pediatric), Transesophageal, Transrectal, Transvaginal, Intraoperative and Imaging guidance for interventional procedures (e.g. Nerve block, biopsy, vascular access).

Source page: https://510kreport.com/device/K183362
Methodology: https://510kreport.com/methodology