K220928 is an FDA 510(k) clearance for the Overjet Calculus Assist. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Overjet, Inc. (Boston, US). The FDA issued a Cleared decision on December 16, 2022, 260 days after receiving the submission on March 31, 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 | K220928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2022 |
| Decision Date | December 16, 2022 |
| Days to Decision | 260 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 |