Medical Device Manufacturer · US , Sound Beach , NY

VATECH Co., Ltd.

39 submissions · 39 cleared · Since 2008
39
Total
39
Cleared
0
Denied

VATECH Co., Ltd. — FDA 510(k) Submissions

VATECH Co., Ltd. has submitted 39 FDA 510(k) premarket notifications since 2008, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include X-ray, Tomography, Computed, Dental, System, X-ray, Extraoral Source, Digital, Unit, X-ray, Extraoral With Timer, System, X-ray, Tomography, Computed, System, X-ray, Mobile . Use the specialty filter in the sidebar to narrow results.

39 devices
1–25 of 39
Green X 12 SE (PHT-40CHS)
K243088 · OAS X-ray, Tomography,... · Radiology
Feb 2025 144d
Green X 21 (PHT-90CHO)
K243081 · OAS X-ray, Tomography,... · Radiology
Feb 2025 137d
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)
K240040 · MUH System, X-ray, Extraoral... · Radiology
Oct 2024 294d
Grreen X 12 (Model: PHT-75CHS)
K231796 · OAS X-ray, Tomography,... · Radiology
Jul 2023 29d
EzRay Air 2 Wall (Model: VEX-S350W)
K223058 · EHD Unit, X-ray, Extraoral... · Radiology
Oct 2022 26d
EzRay M18 (Model: VMX-P400)
K213462 · IZL System, X-ray, Mobile · Radiology
Feb 2022 107d
Green X 18(Model : PHT-75CHS)
K210329 · OAS X-ray, Tomography,... · Radiology
Feb 2021 14d
EzRay M (Model: VMX-P300)
K203667 · IZL System, X-ray, Mobile · Radiology
Feb 2021 48d
vatech A9 (Model : PHT-30CSS)
K203797 · OAS X-ray, Tomography,... · Radiology
Jan 2021 28d
Dental Computed Tomography X-Ray System, Green X
K201627 · OAS X-ray, Tomography,... · Radiology
Oct 2020 133d
EzRay Air Portable (Model: VEX-P300)
K200182 · EHD Unit, X-ray, Extraoral... · Radiology
Feb 2020 18d
Green16/Green18 (Model: PHT-65LHS)
K170066 · OAS X-ray, Tomography,... · Radiology
Jun 2017 158d
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
K170731 · MUH System, X-ray, Extraoral... · Radiology
Apr 2017 25d
EzRay Air W
K163705 · EHD Unit, X-ray, Extraoral... · Radiology
Jan 2017 26d
PaX-i3D Green Premium (Model: PCT-90LH)
K160882 · OAS X-ray, Tomography,... · Radiology
Oct 2016 211d
Green Smart (Model: PHT-35LHS)
K162660 · OAS X-ray, Tomography,... · Radiology
Oct 2016 24d
EzRay Air (Model VEX-P300)
K161063 · EHD Unit, X-ray, Extraoral... · Radiology
Sep 2016 139d
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
K152106 · OAS X-ray, Tomography,... · Radiology
Oct 2015 86d
TON-95LH, PAX-I3D ORTHO
K132983 · OAS X-ray, Tomography,... · Radiology
Aug 2014 318d
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K130585 · MUH System, X-ray, Extraoral... · Radiology
Jul 2013 132d
PHT-6500, PHT-60CFO
K130432 · OAS X-ray, Tomography,... · Radiology
May 2013 99d
VEX-S 100W INTRAORAL X-RAY SYSTEM
K123493 · EHD Unit, X-ray, Extraoral... · Radiology
Dec 2012 34d
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K122155 · MUH System, X-ray, Extraoral... · Radiology
Sep 2012 46d
PAX-UNI3D, PHT-7500
K121400 · OAS X-ray, Tomography,... · Radiology
Aug 2012 110d
PAX-FLEX3D, PHT-7000
K121412 · OAS X-ray, Tomography,... · Radiology
Jun 2012 28d
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