K171353 is an FDA 510(k) clearance for the CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Minxray, Inc. (Northbrook, US). The FDA issued a Cleared decision on June 7, 2017, 29 days after receiving the submission on May 9, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K171353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2017 |
| Decision Date | June 07, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |