# K014206: Logiqbook

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Jan 16, 2002 after 26 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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: 3 generations back to K863700 (1987). 3 ancestors in all.
667 later devices descend from it; 4 cite it directly.
2 of 671 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953752: RT55 Diagnostic Ultrasound System, General Electric Co. (1996) Summary page 1.
- K012560: GE Logiq A100 MP, Model 2272413, General Electric Co. (2001) Summary page 1.

## Most influential descendants
- K032477: GE Logiq Book (2003), 666 descendants of its own
- K050126: GE Logiq Twin (2005), 665 descendants of its own
- K072797: GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact Ultrasound (2007), 664 descendants of its own
- K091164: GE Venue 40, Model 5324338 (2009), 605 descendants of its own
- K091374: GE Logiq I/E & Vivid E Compact Ultrasound (2009), 521 descendants of its own

## Recalls of this device
- Sep 2, 2004 · Not classified · Z-0387-06: 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/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transrectal; and Transvaginal.

Source page: https://510kreport.com/device/K014206
Methodology: https://510kreport.com/methodology