K803049 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY CHEST DEVICE. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1981, 91 days after receiving the submission on December 1, 1980.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K803049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1980 |
| Decision Date | March 02, 1981 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |