K203281 is an FDA 510(k) clearance for the Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Medphoton GmbH (Salzburg, AT). The FDA issued a Cleared decision on December 22, 2020, 46 days after receiving the submission on November 6, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K203281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2020 |
| Decision Date | December 22, 2020 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |