# K020263: LOGIQ 3

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Feb 6, 2002 after 12 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: 2 generations back to K010329 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014097: GE Logiq 5, GE Medical Systems (2002) Summary page 1.

## Most influential descendants
- K072075: Modification to GE Logiq A3 (2007), 0 descendants of its own

## Recalls of this device
- Sep 4, 2007 · Not classified · Z-1155-2008: Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biops

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Intraoperative, Transrectal; and Transvaginal.

Source page: https://510kreport.com/device/K020263
Methodology: https://510kreport.com/methodology