# K214039: Logiq P10, Logiq P9, Logiq P8

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Mar 22, 2022 after 89 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K935595 (1995). 149 ancestors in all.
No later device cites it as a predicate yet.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203114: Logiq P10, Logiq P9, Logiq P8, GE Medical Systems Ultrasound and Primary Care Diagnostics (2021) Summary page 4.

## Recalls of this device
- Sep 18, 2025 · Class II · Z-0155-2026: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impactin
- Sep 18, 2025 · Class II · Z-0157-2026: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impactin
- Sep 18, 2025 · Class II · Z-0156-2026: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impactin

## Indications for use
The LOGIQ P8/P9/P10 is intended for use by a qualified physician for ultrasound 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 P8/P9/P10 is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K214039
Methodology: https://510kreport.com/methodology