# K161047: LOGIQ P9 and LOGIQ P7

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: May 5, 2016 after 22 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: 20 generations back to K935595 (1995). 145 ancestors in all.
107 later devices descend from it; 2 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143452: Logiq P9, Logiq P7, GE Healthcare (2015) Summary page 12.

## Most influential descendants
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K163596: LOGIQ P9 and LOGIQ P7 (2017), 47 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own
- K170493: HS50 / HS60 Diagnostic Ultrasound System (2017), 37 descendants of its own
- K172129: HS40 Diagnostic Ultrasound System (2017), 35 descendants of its own

## 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); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

Source page: https://510kreport.com/device/K161047
Methodology: https://510kreport.com/methodology