Philips Lumify Diagnostic Ultrasound System
FDA 510(k) clearance K152899 · decided 2015-10-30
Clearance details
- K-number
- K152899
- Device name
- Philips Lumify Diagnostic Ultrasound System
- Applicant
- Philips Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-01
- Decision date
- 2015-10-30
- Days to decision
- 29 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 |
|---|---|---|
| C5-2 Lumify Transducer Probe recall (Z-2354-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| L12-4 Transducer Probe recall (Z-2373-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| L12-4 Lumify Transducer Probe recall (Z-2374-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 w recall (Z-0596-2016) | Philips Ultrasound, Inc. | 2016-01-06 |