K854510 is an FDA 510(k) clearance for the MINXRAY 500M MAMMOGRAPHIC SYSTEM. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Minxray, Inc. (Evanston, US). The FDA issued a Cleared decision on January 1, 1986, 50 days after receiving the submission on November 12, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K854510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1985 |
| Decision Date | January 01, 1986 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | IZH - System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |