# K181783: Logiq P9; Logiq P7

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 20, 2018 after 79 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: 22 generations back to K935595 (1995). 147 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163596: LOGIQ P9 and LOGIQ P7, GE Healthcare (2017) Summary page 32.

## Most influential descendants
- K183362: Venue GO (2019), 14 descendants of its own
- K203137: Venue Fit (2020), 5 descendants of its own
- K220848: Venue Fit (2022), 4 descendants of its own
- K202233: Venue Go (2020), 4 descendants of its own
- K220800: Venue Go (2022), 3 descendants of its own

## Recalls of this device
- Jul 2, 2019 · Class II · Z-1965-2019: Potential for a transducer mis-alignment in certain transvaginal probes.

## 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; Transesophageal and Intraoperative (abdominal, thoracic, vascular). When Pinpoint 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/K181783
Methodology: https://510kreport.com/methodology