K223133 is an FDA 510(k) clearance for the VisiRad XR. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Imidex, Inc. (Denver, US). The FDA issued a Cleared decision on August 3, 2023, 304 days after receiving the submission on October 3, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers.
| 510(k) Number | K223133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2022 |
| Decision Date | August 03, 2023 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN - Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| Definition | For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers |