K173395 is an FDA 510(k) clearance for the MECALL CLISIS SYSTEMS, Discovery RF180. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by General Medical Merate S.P.A (Seriate, IT). The FDA issued a Cleared decision on May 21, 2018, 203 days after receiving the submission on October 30, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K173395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2017 |
| Decision Date | May 21, 2018 |
| Days to Decision | 203 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |