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 Acquisition Console.
| Device ID | K123650 |
| 510k Number | K123650 |
| Device Name: | ARIX RAD ACQUISITION CONSOLE |
| Classification | System, Image Processing, Radiological |
| Applicant | COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-27 |
| Decision Date | 2013-02-20 |
| Summary: | summary |