# K091374: GE Logiq I/E & Vivid E Compact Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: May 26, 2009 after 15 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K863700 (1987). 8 ancestors in all.
521 later devices descend from it; 4 cite it directly.
0 of 530 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.
- K091164: GE Venue 40, Model 5324338, Ge Medical Systems China Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- 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
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 (2013), 270 descendants of its own

## Indications for use
The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Source page: https://510kreport.com/device/K091374
Methodology: https://510kreport.com/methodology