# K112122: VENUE 40

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 23, 2011 after 60 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: 10 generations back to K863700 (1987). 15 ancestors in all.
160 later devices descend from it; 2 cite it directly.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102113: GE Venue 40 Compact Diagnostic Ultrasound, Ge Medical Systems China Co., Ltd. (2010) Summary page 1.
- K102256: GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound, Ge Medical Systems China Co., Ltd. (2010) Summary page 1.
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K142466: UGEO PT60A Diagnostic Ultrasound System (2014), 99 descendants of its own
- K143264: H60 V2.00 Diagnostic Ultrasound System (2014), 98 descendants of its own
- K150478: A35 Diagnostic Ultrasound System (2015), 97 descendants of its own
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own

## Indications for use
The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: 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/K112122
Methodology: https://510kreport.com/methodology