K243081 is an FDA 510(k) clearance for the Green X 21 (PHT-90CHO). This device is classified as a X-ray, Tomography, Computed, Dental (Class II - Special Controls, product code OAS).
Submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 14, 2025, 137 days after receiving the submission on September 30, 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 | K243081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | February 14, 2025 |
| Days to Decision | 137 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. |