Flash Ultrasound System 5100 Point of Care
FDA 510(k) clearance K250030 · decided 2025-04-28
Clearance details
- K-number
- K250030
- Device name
- Flash Ultrasound System 5100 Point of Care
- Applicant
- Philips Ultrasound, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-01-06
- Decision date
- 2025-04-28
- Days to decision
- 112 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
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| eL18-4 Transducer Probe recall (Z-2369-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| mL26-8 Transducer Probe recall (Z-2386-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| X8-2t Transducer Probe recall (Z-2413-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| XL14-3 Transducer Probe recall (Z-2414-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Philips XL14-3 Transducer. recall (Z-2068-2025) | Philips Ultrasound, Inc | 2025-07-02 |