# K014097: GE Logiq 5

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Jan 10, 2002 after 29 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: 1 generation back to K010329 (2001). 1 ancestor in all.
657 later devices descend from it; 2 cite it directly.
0 of 659 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010329: LOGIQ 500, General Electric Co. (2001) Summary page 1.

## Most influential descendants
- K032974: GE Logiq 5 Pro or Expert (2003), 654 descendants of its own
- K060993: GE Logiq P5 and A5 (2006), 653 descendants of its own
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Recalls of this device
- Sep 2, 2004 · Not classified · Z-0386-06: The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next pati

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurological).

Source page: https://510kreport.com/device/K014097
Methodology: https://510kreport.com/methodology