EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
FDA 510(k) clearance K201012 · decided 2020-05-01
Clearance details
- K-number
- K201012
- Device name
- EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-17
- Decision date
- 2020-05-01
- Days to decision
- 14 days
- Clearance type
- Special
- 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 |
|---|---|---|
| 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 Lumify Transducer Probe recall (Z-2392-2025) | Philips Ultrasound, Inc | 2025-08-22 |