K210957 is an FDA 510(k) clearance for the Kubec Xpert 80 Radiography System. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Kub Technologies, Inc. (Stratford, US). The FDA issued a Cleared decision on August 31, 2021, 154 days after receiving the submission on March 30, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K210957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2021 |
| Decision Date | August 31, 2021 |
| Days to Decision | 154 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MWP - Cabinet, X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |