The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Philips Integris Allura Flat Detector Release 1.0.
| Device ID | K022899 |
| 510k Number | K022899 |
| Device Name: | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2002-11-22 |
| Summary: | summary |