VATECH Co., Ltd.
Medical device manufacturer in Hwaseong-Si, KR.
40510(k) clearances
0PMA approvals
0recalls
Device types
- OAS X-Ray, Tomography, Computed, Dental 19
- MUH System, X-Ray, Extraoral Source, Digital 8
- EHD Unit, X-Ray, Extraoral With Timer 6
- JAK System, X-Ray, Tomography, Computed 2
- IZL System, X-Ray, Mobile 2
- KPR System, X-Ray, Stationary 1
- MQB Solid State X-Ray Imager (Flat… 1
- LLZ System, Image Processing, Radiological 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special | 03/31/2026SE |
| K243088 | Green X 12 SE (PHT-40CHS)OAS · Special | 02/21/2025SE |
| K243081 | Green X 21 (PHT-90CHO)OAS · Traditional | 02/14/2025SE |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional | 10/25/2024SE |
| K231796 | Grreen X 12 (Model: PHT-75CHS)OAS · Special | 07/19/2023SE |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W)EHD · Special | 10/26/2022SE |
| K213462 | EzRay M18 (Model: VMX-P400)IZL · Traditional | 02/11/2022SE |
| K210329 | Green X 18(Model : PHT-75CHS)OAS · Special | 02/18/2021SE |
| K203667 | EzRay M (Model: VMX-P300)IZL · Traditional | 02/02/2021SE |
| K203797 | vatech A9 (Model : PHT-30CSS)OAS · Special | 01/25/2021SE |
| K201627 | Dental Computed Tomography X-Ray System, Green XOAS · Traditional | 10/27/2020SE |
| K200182 | EzRay Air Portable (Model: VEX-P300)EHD · Special | 02/11/2020SE |
| K170066 | Green16/Green18 (Model: PHT-65LHS)OAS · Traditional | 06/16/2017SE |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightMUH · Traditional | 04/04/2017SE |
| K163705 | EzRay Air WEHD · Special | 01/24/2017SE |
| K160882 | PaX-i3D Green Premium (Model: PCT-90LH)OAS · Traditional | 10/28/2016SE |
| K162660 | Green Smart (Model: PHT-35LHS)OAS · Special | 10/20/2016SE |
| K161063 | EzRay Air (Model VEX-P300)EHD · Traditional | 09/01/2016SE |
| K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartOAS · Traditional | 10/23/2015SE |
| K132983 | TON-95LH, PAX-I3D OrthoOAS · Traditional | 08/07/2014SE |
| K130585 | PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source X-Ray…MUH · Traditional | 07/15/2013SE |
| K130432 | PHT-6500, PHT-60CFOOAS · Special | 05/31/2013SE |
| K123493 | Vex-S 100W Intraoral X-Ray SystemEHD · Special | 12/13/2012SE |
| K122155 | PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray SystemMUH · Special | 09/04/2012SE |
| K121400 | PAX-UNI3D, PHT-7500OAS · Special | 08/28/2012SE |
| K121412 | PAX-FLEX3D, PHT-7000OAS · Special | 06/08/2012SE |
| K121236 | PAX-DUO3D Plus, PCT-5000OAS · Special | 05/24/2012SE |
| K113672 | PCH-2500 Digital Extraoral Source X-Ray SystemMUH · Traditional | 03/27/2012SE |
| K102078 | Radiological Image Processing SystemLLZ · Traditional | 08/10/2011SE |
| K102196 | Computed Tomography X-Ray SystemOAS · Traditional | 03/25/2011SE |
| K102102 | Computed Tomography X-Ray SystemJAK · Traditional | 03/11/2011SE |
| K102259 | Dental Computed Tomography X-Ray SystemJAK · Traditional | 02/18/2011SE |
| K101590 | Digital Flat Panel X-Ray DetectorMQB · Traditional | 11/29/2010SE |
| K102124 | Dental Computed Tomography X-Ray SystemMUH · Traditional | 10/22/2010SE |
| K092830 | Digital X-Ray Imaging System, Model DRC-1000KPR · Traditional | 07/21/2010SE |
| K100317 | Digital X-Ray Imaging System (Pax-Primo) Model Pax-PrimoMUH · Traditional | 03/24/2010SE |
| K090467 | Digital X-Ray Imaging System, Model PAX-UNI3DOAS · Traditional | 01/08/2010SE |
| K092103 | Dental Extraoral Source X-Ray System (Esx)EHD · Traditional | 10/09/2009SE |
| K082350 | PAX-500OAS · Traditional | 10/10/2008SE |
| K073365 | Dental Digital X-Ray Imaging SystemMUH · Traditional | 04/08/2008SE |