K221921 is an FDA 510(k) clearance for the DTX Studio Clinic 3.0. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Nobel Biocare AB (411 17 Goteborg, SE). The FDA issued a Cleared decision on March 28, 2023, 270 days after receiving the submission on July 1, 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 | K221921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2022 |
| Decision Date | March 28, 2023 |
| Days to Decision | 270 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 |