PHILIPS OMNIDIAGNOST
FDA 510(k) clearance K982993 · decided 1998-09-29
Clearance details
- K-number
- K982993
- Device name
- PHILIPS OMNIDIAGNOST
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-27
- Decision date
- 1998-09-29
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Da Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, recall (Z-2301-2018) | Philips Medical Systems Nederlands | 2018-06-27 |
| OmniDiagnost recall (Z-1665-2009) | Philips Medical Systems North America Co. Phillips | 2009-09-24 |
| OmniDiagnost System recall (Z-0874-03) | Philips Medical Systems Sales & Service Region No. America | 2004-07-20 |