PHILIPS EASYVISION
FDA 510(k) clearance K963980 · decided 1996-12-23
Clearance details
- K-number
- K963980
- Device name
- PHILIPS EASYVISION
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-03
- Decision date
- 1996-12-23
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3 recall (Z-2053-2008) | Philips Medical Systems North America Co. Phillips | 2008-09-16 |