# K203114: Logiq P10, Logiq P9, Logiq P8

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jan 8, 2021 after 85 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: 23 generations back to K935595 (1995). 148 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181783: Logiq P9; Logiq P7, GE Healthcare (2018) Summary page 5.

## Most influential descendants
- K214039: Logiq P10, Logiq P9, Logiq P8 (2022), 0 descendants of its own

## Indications for use
The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 clinical applications include: evaluation of Fetal/Obstetrics; 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, vascular). Modes of operation include: B, M, PW, Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K203114
Methodology: https://510kreport.com/methodology