PHILLIPS OMNIDIAGNOST ELEVA
FDA 510(k) clearance K032046 · decided 2003-07-17
Clearance details
- K-number
- K032046
- Device name
- PHILLIPS OMNIDIAGNOST ELEVA
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-02
- Decision date
- 2003-07-17
- Days to decision
- 15 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
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, recall (Z-2300-2018) | Philips Medical Systems Nederlands | 2018-06-27 |
| Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoros recall (Z-1657-2011) | Philips Medical Systems North America Co. Phillips | 2011-03-16 |
| Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips OmniDiagnost recall (Z-0918-2011) | Philips Medical Systems North America Co. Phillips | 2011-01-18 |
| OminDiagnost Eleva recall (Z-0352-2009) | Philips Medical Systems North America Co. Phillips | 2009-09-24 |
| Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiog recall (Z-1374-2008) | Philips Medical Systems North America Co. Phillips | 2008-09-16 |
| Philips Omni Diagnost Eleva recall (Z-0911-2007) | Philips Medical Systems North America Co. Phillips | 2007-09-25 |