K904012 is an FDA 510(k) clearance for the PHILIPS INTEGRIS I 2000 SYSTEM. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on November 29, 1990, 92 days after receiving the submission on August 29, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K904012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1990 |
| Decision Date | November 29, 1990 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |