LOGIQ P10, LOGIQ P9, LOGIQ P8
FDA 510(k) clearance K214039 · decided 2022-03-22
Clearance details
- K-number
- K214039
- Device name
- LOGIQ P10, LOGIQ P9, LOGIQ P8
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2021-12-23
- Decision date
- 2022-03-22
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch GE Medical Systems Ultrasound and Primary Care Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LOGIQ P10 series with software version R4.5.7 Model Number 5877534 recall (Z-0155-2026) | GE Medical Systems, LLC | 2025-10-15 |
| LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 587 recall (Z-0156-2026) | GE Medical Systems, LLC | 2025-10-15 |
| LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 recall (Z-0157-2026) | GE Medical Systems, LLC | 2025-10-15 |