# K101878: GE Logiq P5 Model H44662LD

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Aug 31, 2010 after 56 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 2.
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 2.

## Indications for use
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).

Source page: https://510kreport.com/device/K101878
Methodology: https://510kreport.com/methodology