K242805 is an FDA 510(k) clearance for the Dental Cone-beam Computed Tomography (FinScan F350). This device is classified as a X-ray, Tomography, Computed, Dental (Class II - Special Controls, product code OAS).
Submitted by Changzhou Finno Medical Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on January 9, 2025, 114 days after receiving the submission on September 17, 2024.
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 | K242805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2024 |
| Decision Date | January 09, 2025 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| 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. |