K203537 is an FDA 510(k) clearance for the Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Sedecal., Sa. (Algete, ES). The FDA issued a Cleared decision on February 1, 2021, 60 days after receiving the submission on December 3, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K203537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2020 |
| Decision Date | February 01, 2021 |
| Days to Decision | 60 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |