K251642 is an FDA 510(k) clearance for the Dental CBCT X-ray System. This device is classified as a X-ray, Tomography, Computed, Dental (Class II - Special Controls, product code OAS).
Submitted by Yian Medical Technology (Haining) Co., Ltd. (Haining, Jiaxing, CN). The FDA issued a Cleared decision on June 27, 2025, 29 days after receiving the submission on May 29, 2025.
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 | K251642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2025 |
| Decision Date | June 27, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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. |