K193637 is an FDA 510(k) clearance for the MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (El Marques, Queretaro, MX). The FDA issued a Cleared decision on January 28, 2020, 32 days after receiving the submission on December 27, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K193637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2019 |
| Decision Date | January 28, 2020 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |