K182134 is an FDA 510(k) clearance for the ARiX RAD 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 November 26, 2018, 112 days after receiving the submission on August 6, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K182134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2018 |
| Decision Date | November 26, 2018 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| 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 |