K862452 is an FDA 510(k) clearance for the MX MOBILE X-RAY SYSTEM. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on July 22, 1986, 25 days after receiving the submission on June 27, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K862452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1986 |
| Decision Date | July 22, 1986 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |