K161518 is an FDA 510(k) clearance for the PACS CORE/ENCORE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (El Marques Queretaro, MX). The FDA issued a Cleared decision on August 17, 2016, 76 days after receiving the submission on June 2, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K161518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2016 |
| Decision Date | August 17, 2016 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |