K082627 is an FDA 510(k) clearance for the MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Minxray, Inc. (Deer Field, US). The FDA issued a Cleared decision on November 7, 2008, 59 days after receiving the submission on September 9, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K082627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2008 |
| Decision Date | November 07, 2008 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL - System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |