PHILIPS BV-29 IMAGING SYSTEM
FDA 510(k) clearance K910115 · decided 1991-02-20
Clearance details
- K-number
- K910115
- Device name
- PHILIPS BV-29 IMAGING SYSTEM
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-10
- Decision date
- 1991-02-20
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- OXO
- 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 |
|---|---|---|
| BV25 Mobile X-Ray System recall (Z-1453-04) | Philips Medical Systems Sales & Service Region No. America | 2004-09-15 |
| BV29 Mobile X-Ray System recall (Z-1456-04) | Philips Medical Systems Sales & Service Region No. America | 2004-09-15 |
| BV212 Mobile X-Ray System recall (Z-1457-04) | Philips Medical Systems Sales & Service Region No. America | 2004-09-15 |