K022899 is an FDA 510(k) clearance for the PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on November 22, 2002, 80 days after receiving the submission on September 3, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K022899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2002 |
| Decision Date | November 22, 2002 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |