PHILIPS URO DIAGNOST MRF
FDA 510(k) clearance K911098 · decided 1991-07-03
Clearance details
- K-number
- K911098
- Device name
- PHILIPS URO DIAGNOST MRF
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-12
- Decision date
- 1991-07-03
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- IXR
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 5680 Da Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, recall (Z-1604-2018) | Philips Medical Systems Nederlands | 2018-05-03 |