K223816 is an FDA 510(k) clearance for the Dental CT Scanner AXR. This device is classified as a X-ray, Tomography, Computed, Dental (Class II - Special Controls, product code OAS).
Submitted by Alliage S/A Industrias Medico Odontol?gica (Recreio Anhanguera, BR). The FDA issued a Cleared decision on April 7, 2023, 108 days after receiving the submission on December 20, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750. Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth..
| 510(k) Number | K223816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2022 |
| Decision Date | April 07, 2023 |
| Days to Decision | 108 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OAS - X-ray, Tomography, Computed, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |
| Definition | Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth. |