PHILIPS INTEGRIS H/HM SYSTEM
FDA 510(k) clearance K925302 · decided 1992-12-17
Clearance details
- K-number
- K925302
- Device name
- PHILIPS INTEGRIS H/HM SYSTEM
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-21
- Decision date
- 1992-12-17
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- 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 |
|---|---|---|
| Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular im recall (Z-3237-2018) | Philips Electronics North America Corporation | 2018-09-21 |
| Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascula recall (Z-3238-2018) | Philips Electronics North America Corporation | 2018-09-21 |
| Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular recall (Z-3239-2018) | Philips Electronics North America Corporation | 2018-09-21 |
| AD5 table for use with Integris and Integris Allura x-ray systems recall (Z-0206-06) | Philips Medical Systems North America Co. Phillips | 2005-11-29 |
| AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt ver recall (Z-0207-06) | Philips Medical Systems North America Co. Phillips | 2005-11-29 |