VATECH Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243088Green X 12 SE (PHT-40CHS)February 21, 2025
K243081Green X 21 (PHT-90CHO)February 14, 2025
K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProOctober 25, 2024
K231796Grreen X 12 (Model: PHT-75CHS)July 19, 2023
K223058EzRay Air 2 Wall (Model: VEX-S350W)October 26, 2022
K213462EzRay M18 (Model: VMX-P400)February 11, 2022
K210329Green X 18(Model : PHT-75CHS)February 18, 2021
K203667EzRay M (Model: VMX-P300)February 2, 2021
K203797vatech A9 (Model : PHT-30CSS)January 25, 2021
K201627Dental Computed Tomography X-Ray System, Green XOctober 27, 2020
K200182EzRay Air Portable (Model: VEX-P300)February 11, 2020
K170066Green16/Green18 (Model: PHT-65LHS)June 16, 2017
K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightApril 4, 2017
K163705EzRay Air WJanuary 24, 2017
K160882PaX-i3D Green Premium (Model: PCT-90LH)October 28, 2016
K162660Green Smart (Model: PHT-35LHS)October 20, 2016
K161063EzRay Air (Model VEX-P300)September 1, 2016
K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartOctober 23, 2015
K132983TON-95LH, PAX-I3D ORTHOAugust 7, 2014
K130585PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMJuly 15, 2013