K193317 is an FDA 510(k) clearance for the CoreLite X-Ray Specimen Cabinet. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Cirdan Imaging Limited (Lisburn, GB). The FDA issued a Cleared decision on December 13, 2019, 14 days after receiving the submission on November 29, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K193317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2019 |
| Decision Date | December 13, 2019 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| 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 |