PHILIPS COMPUTED RADIOGRAPHY
FDA 510(k) clearance K964124 · decided 1996-12-18
Clearance details
- K-number
- K964124
- Device name
- PHILIPS COMPUTED RADIOGRAPHY
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-15
- Decision date
- 1996-12-18
- Days to decision
- 64 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 |
|---|---|---|
| PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc recall (Z-3205-2011) | Philips Healthcare Inc. | 2011-09-14 |
| PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of recall (Z-1019-2011) | Philips Medical Systems North America Co. Phillips | 2011-02-04 |