PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
FDA 510(k) clearance K141736 · decided 2014-07-25
Clearance details
- K-number
- K141736
- Device name
- PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
- Applicant
- Philips Medical Systems Dmc GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-06-27
- Decision date
- 2014-07-25
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hamburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Healthcare DigitalDiagnost stationary X-ray system recall (Z-1695-2016) | Philips Healthcare | 2016-06-03 |
| Philips Healthcare DigitalDiagnost System X-Ray recall (Z-1554-2015) | Philips Medical Systems, Inc. | 2015-05-19 |