LOGIQ P10, LOGIQ P9, LOGIQ P8— 510(k) K214039
Substantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnostics
FDA 510(k) clearance K214039 for LOGIQ P10, LOGIQ P9, LOGIQ P8, Substantially Equivalent on 2022-03-22. Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Product code
- Code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
Recent devices under product code IYN
view all- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
- K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus
- K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
More clearances from GE Medical Systems Ultrasound and Primary Care Diagnostics
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K214039
K-number listed on FDA's recall record- Z-0155-2026 — LOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Z-0156-2026 — LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
- Z-0157-2026 — LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K214039.
Data sourced from openFDA. This site is unofficial and independent of the FDA.