K230144 is an FDA 510(k) clearance for the Denti.AI Detect. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Denti.Ai Technology, Inc. (Toronto, CA). The FDA issued a Cleared decision on October 6, 2023, 261 days after receiving the submission on January 18, 2023.
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 | K230144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2023 |
| Decision Date | October 06, 2023 |
| Days to Decision | 261 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 |