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VATECH Co., Ltd.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories4
Latest FDA decision2026-03-31
TypeNumberDevice NameCodeDateActions
510(k) K260093 Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS2026-03-31 View
510(k) K243088 Green X 12 SE (PHT-40CHS)OAS2025-02-21 View
510(k) K243081 Green X 21 (PHT-90CHO)OAS2025-02-14 View
510(k) K240040 VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)MUH2024-10-25 View
510(k) K231796 Grreen X 12 (Model: PHT-75CHS)OAS2023-07-19 View
510(k) K223058 EzRay Air 2 Wall (Model: VEX-S350W)EHD2022-10-26 View
510(k) K213462 EzRay M18 (Model: VMX-P400)IZL2022-02-11 View
510(k) K210329 Green X 18(Model : PHT-75CHS)OAS2021-02-18 View
510(k) K203667 EzRay M (Model: VMX-P300)IZL2021-02-02 View
510(k) K203797 vatech A9 (Model : PHT-30CSS)OAS2021-01-25 View
510(k) K201627 Dental Computed Tomography X-Ray System, Green XOAS2020-10-27 View
510(k) K200182 EzRay Air Portable (Model: VEX-P300)EHD2020-02-11 View
510(k) K170066 Green16/Green18 (Model: PHT-65LHS)OAS2017-06-16 View
510(k) K170731 System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightMUH2017-04-04 View
510(k) K163705 EzRay Air WEHD2017-01-24 View
510(k) K160882 PaX-i3D Green Premium (Model: PCT-90LH)OAS2016-10-28 View
510(k) K162660 Green Smart (Model: PHT-35LHS)OAS2016-10-20 View
510(k) K161063 EzRay Air (Model VEX-P300)EHD2016-09-01 View