# K163596: LOGIQ P9 and LOGIQ P7

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Feb 10, 2017 after 51 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: 21 generations back to K935595 (1995). 146 ancestors in all.
47 later devices descend from it; 6 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161047: LOGIQ P9 and LOGIQ P7, GE Healthcare (2016) Summary page 28.

## Most influential descendants
- K170714: Venue (2017), 35 descendants of its own
- K180599: Venue (2018), 28 descendants of its own
- K181783: Logiq P9; Logiq P7 (2018), 17 descendants of its own
- K183362: Venue GO (2019), 14 descendants of its own
- K181727: Vivid iq (2018), 9 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). When PinpointTM GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data

Source page: https://510kreport.com/device/K163596
Methodology: https://510kreport.com/methodology