K082350 is an FDA 510(k) clearance for the PAX-500. This device is classified as a X-ray, Tomography, Computed, Dental (Class II - Special Controls, product code OAS).
Submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on October 10, 2008, 56 days after receiving the submission on August 15, 2008.
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 | K082350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2008 |
| Decision Date | October 10, 2008 |
| Days to Decision | 56 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. |