Lumify Diagnostic Ultrasound System
FDA 510(k) clearance K192226 · decided 2019-09-06
Clearance details
- K-number
- K192226
- Device name
- Lumify Diagnostic Ultrasound System
- Applicant
- Philips Health Care
- Decision
- Substantially Equivalent
- Date received
- 2019-08-16
- Decision date
- 2019-09-06
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips S4-1 Ultrasound Transducer recall (Z-1625-2026) | Philips Ultrasound, Inc | 2026-03-24 |
| C5-2 Lumify Transducer Probe recall (Z-2354-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| L12-4 Lumify Transducer Probe recall (Z-2374-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| S4-1 Transducer Probe recall (Z-2391-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| S4-1 Lumify Transducer Probe recall (Z-2392-2025) | Philips Ultrasound, Inc | 2025-08-22 |