K192939 is an FDA 510(k) clearance for the Volumetric Specimen Imager. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Clarix Imaging (Chicago, US). The FDA issued a Cleared decision on December 27, 2019, 70 days after receiving the submission on October 18, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K192939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2019 |
| Decision Date | December 27, 2019 |
| Days to Decision | 70 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 |