PHILIPS DIAGNOST 96
FDA 510(k) clearance K912470 · decided 1991-08-07
Clearance details
- K-number
- K912470
- Device name
- PHILIPS DIAGNOST 96
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-04
- Decision date
- 1991-08-07
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- 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 |
|---|---|---|
| Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a mul recall (Z-2765-2011) | Philips Healthcare Inc. | 2011-07-08 |
| Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems. recall (Z-0097-04) | Philips Medical Systems Sales & Service Region No. America | 2004-07-20 |
| Diagnost 97 recall (Z-1242-03) | Philips Medical Systems Sales & Service Region No. America | 2004-07-20 |
| Diagnost 94 recall (Z-1203-03) | Philips Medical Systems | 2003-09-12 |
| Multidiagnost 96 recall (Z-1204-03) | Philips Medical Systems | 2003-09-12 |
| Multidiagnost 97 recall (Z-1205-03) | Philips Medical Systems | 2003-09-12 |
| Diagnost 96 recall (Z-1212-03) | Philips Medical Systems Sales & Service Region No. America | 2003-09-11 |
| Diagnost 97 recall (Z-1213-03) | Philips Medical Systems Sales & Service Region No. America | 2003-09-11 |
| Diagnost 94 recall (Z-1214-03) | Philips Medical Systems Sales & Service Region No. America | 2003-09-11 |