The following data is part of a premarket notification filed by Compania Mexicana De Radiologia Cgr, S.a. De C.v. with the FDA for Arix Rad Radiographic System.
| Device ID | K182134 |
| 510k Number | K182134 |
| Device Name: | ARiX RAD Radiographic System |
| Classification | System, X-ray, Stationary |
| Applicant | Compania Mexicana De Radiologia CGR, S.A. DE C.V. Fraccionamiento Industrial La Noria S/N El Marques, Queretaro, MX 76240 |
| Contact | Tonatiuh Monroy Soberon |
| Correspondent | Stuart R. Goldman Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 Austin, TX 78746 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2018-11-26 |
| Summary: | summary |