# K113690: GE Logiq I, Logiq E and Vivid E

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Dec 29, 2011 after 14 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K935595 (1995). 107 ancestors in all.
469 later devices descend from it; 12 cite it directly.
0 of 577 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102256: GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound, Ge Medical Systems China Co., Ltd. (2010) Summary page 1.
- K110943: Logiq E9, GE Healthcare (2011) Summary page 1.

## Most influential descendants
- 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
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 (2013), 255 descendants of its own

## Recalls of this device
- Nov 9, 2012 · Class II · Z-1849-2013: GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.

## 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, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Source page: https://510kreport.com/device/K113690
Methodology: https://510kreport.com/methodology