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 Pacs Core/encore.
| Device ID | K161518 |
| 510k Number | K161518 |
| Device Name: | PACS CORE/ENCORE |
| Classification | System, Image Processing, Radiological |
| Applicant | COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. FRACCIONAMIENTO INDUSTRIAL S/N El Marques Queretaro, MX 76240 |
| Contact | Felipe Cuaranta Monroy |
| Correspondent | Carl Alletto OTECH INC. 8317 BELEW DRIVE Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-08-17 |
| Summary: | summary |