# K091164: GE Venue 40, Model 5324338

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: May 5, 2009 after 13 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: 7 generations back to K863700 (1987). 7 ancestors in all.
605 later devices descend from it; 2 cite it directly.
2 of 613 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072797: GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact Ultrasound, General Electric Co. (2007) Summary page 1.

## Most influential descendants
- K091374: GE Logiq I/E & Vivid E Compact Ultrasound (2009), 521 descendants of its own
- K102256: GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound (2010), 511 descendants of its own
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 descendants of its own
- K123564: Logiq E9 Diagnostic Ultrasound System (2012), 323 descendants of its own
- K120741: Voluson S6, Voluson S8 (2012), 295 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; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

Source page: https://510kreport.com/device/K091164
Methodology: https://510kreport.com/methodology