PHILIPS INTEGRIS V5000 AND BV5000
FDA 510(k) clearance K973482 · decided 1997-11-10
Clearance details
- K-number
- K973482
- Device name
- PHILIPS INTEGRIS V5000 AND BV5000
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-15
- Decision date
- 1997-11-10
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- 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 |
|---|---|---|
| INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended fo recall (Z-0722-2016) | Philips Electronics North America Corporation | 2016-01-30 |
| INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended f recall (Z-0723-2016) | Philips Electronics North America Corporation | 2016-01-30 |
| INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended fo recall (Z-0724-2016) | Philips Electronics North America Corporation | 2016-01-30 |
| INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended f recall (Z-0725-2016) | Philips Electronics North America Corporation | 2016-01-30 |