Company ยท US
VATECH Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 19 |
| MUH | System, X-Ray, Extraoral Source, Digital | 8 |
| EHD | Unit, X-Ray, Extraoral With Timer | 6 |
| IZL | System, X-Ray, Mobile | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 |
| KPR | System, X-Ray, Stationary | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2026 | K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) VATECH Co., Ltd., KR | OAS |
| Feb 21, 2025 | K243088 | Green X 12 SE (PHT-40CHS) VATECH Co., Ltd., KR | OAS |
| Feb 14, 2025 | K243081 | Green X 21 (PHT-90CHO) VATECH Co., Ltd., KR | OAS |
| Oct 25, 2024 | 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); P VATECH Co., Ltd., KR | MUH |
| Jul 19, 2023 | K231796 | Grreen X 12 (Model: PHT-75CHS) VATECH Co., Ltd., KR | OAS |
| Oct 26, 2022 | K223058 | EzRay Air 2 Wall (Model: VEX-S350W) VATECH Co., Ltd., KR | EHD |
| Feb 11, 2022 | K213462 | EzRay M18 (Model: VMX-P400) VATECH Co., Ltd., KR | IZL |
| Feb 18, 2021 | K210329 | Green X 18(Model : PHT-75CHS) VATECH Co., Ltd., KR | OAS |
| Feb 2, 2021 | K203667 | EzRay M (Model: VMX-P300) VATECH Co., Ltd., KR | IZL |
| Jan 25, 2021 | K203797 | vatech A9 (Model : PHT-30CSS) VATECH Co., Ltd., KR | OAS |
| Oct 27, 2020 | K201627 | Dental Computed Tomography X-Ray System, Green X VATECH Co., Ltd., KR | OAS |
| Feb 11, 2020 | K200182 | EzRay Air Portable (Model: VEX-P300) VATECH Co., Ltd., KR | EHD |
| Jun 16, 2017 | K170066 | Green16/Green18 (Model: PHT-65LHS) VATECH Co., Ltd., KR | OAS |
| Apr 4, 2017 | K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight VATECH Co., Ltd., KR | MUH |
| Jan 24, 2017 | K163705 | EzRay Air W VATECH Co., Ltd., KR | EHD |
| Oct 28, 2016 | K160882 | PaX-i3D Green Premium (Model: PCT-90LH) VATECH Co., Ltd., KR | OAS |
| Oct 20, 2016 | K162660 | Green Smart (Model: PHT-35LHS) VATECH Co., Ltd., KR | OAS |
| Sep 1, 2016 | K161063 | EzRay Air (Model VEX-P300) VATECH Co., Ltd., KR | EHD |
| Oct 23, 2015 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart VATECH Co., Ltd., KR | OAS |
| Aug 7, 2014 | K132983 | TON-95LH, PAX-I3D ORTHO VATECH Co., Ltd. | OAS |
| Jul 15, 2013 | K130585 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. | MUH |
| May 31, 2013 | K130432 | PHT-6500, PHT-60CFO VATECH Co., Ltd. | OAS |
| Dec 13, 2012 | K123493 | VEX-S 100W INTRAORAL X-RAY SYSTEM VATECH Co., Ltd. | EHD |
| Sep 4, 2012 | K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. | MUH |
| Aug 28, 2012 | K121400 | PAX-UNI3D, PHT-7500 VATECH Co., Ltd. | OAS |
| Jun 8, 2012 | K121412 | PAX-FLEX3D, PHT-7000 VATECH Co., Ltd. | OAS |
| May 24, 2012 | K121236 | PAX-DUO3D PLUS, PCT-5000 VATECH Co., Ltd. | OAS |
| Mar 27, 2012 | K113672 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. | MUH |
| Aug 10, 2011 | K102078 | RADIOLOGICAL IMAGE PROCESSING SYSTEM VATECH Co., Ltd. | LLZ |
| Mar 25, 2011 | K102196 | COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. | OAS |
| Mar 11, 2011 | K102102 | COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. | JAK |
| Feb 18, 2011 | K102259 | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. | JAK |
| Nov 29, 2010 | K101590 | DIGITAL FLAT PANEL X-RAY DETECTOR VATECH Co., Ltd. | MQB |
| Oct 22, 2010 | K102124 | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. | MUH |
| Jul 21, 2010 | K092830 | DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 VATECH Co., Ltd. | KPR |
| Mar 24, 2010 | K100317 | DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO VATECH Co., Ltd. | MUH |
| Jan 8, 2010 | K090467 | DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D VATECH Co., Ltd. | OAS |
| Oct 9, 2009 | K092103 | DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) VATECH Co., Ltd. | EHD |
| Oct 10, 2008 | K082350 | PAX-500 VATECH Co., Ltd. | OAS |
| Apr 8, 2008 | K073365 | DENTAL DIGITAL X-RAY IMAGING SYSTEM VATECH Co., Ltd. | MUH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||