K212557 is an FDA 510(k) clearance for the Virtual C DRF-NEO Digital Imaging System. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Portavision Medical, LLC (Jefferson, US). The FDA issued a Cleared decision on September 24, 2021, 42 days after receiving the submission on August 13, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K212557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2021 |
| Decision Date | September 24, 2021 |
| Days to Decision | 42 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 |