Data / Medical devices / South Korea / Vatech Co., Ltd.
Vatech Co., Ltd.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 23 510(k) clearances
Vatech Co., Ltd. is registered with the FDA (registration 3004706313) in Hwaseong-si Gyeonggi, South Korea. It lists 6 device types. The FDA files 23 510(k) clearances under its listings, the newest dated March 31, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004706313
- Address
- 13, Samsung 1-ro, 2-gil, Hwaseong-si Gyeonggi, South Korea, 18449
- Owner or operator
- VATECH CO., LTD. (9065556)
- Roles
- Manufacturer
- First device listed
- April 19, 2012
- Registered through
- 2026
- Brand names listed
- Green X 12 Plus / Green X Plus (Model: PHT-70CHS), Green X 12 SE (Model : PHT-40CHS), Green X 21 (Model : PHT-90CHO), VistaPano S 2 (Model: VistaPano S), VistaPano S Ceph 2 (Model: VistaPano S Ceph)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 31, 2026 | K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| February 21, 2025 | K243088 | Green X 12 SE (PHT-40CHS) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| February 14, 2025 | K243081 | Green X 21 (PHT-90CHO) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| October 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); ProVecta S-Pan 2.0 (ProVecta S-Pan) | MUH | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| July 19, 2023 | K231796 | Grreen X 12 (Model: PHT-75CHS) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| October 26, 2022 | K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | EHD | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| February 18, 2021 | K210329 | Green X 18(Model : PHT-75CHS) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| February 2, 2021 | K203667 | EzRay M (Model: VMX-P300) | IZL | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| January 25, 2021 | K203797 | vatech A9 (Model : PHT-30CSS) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| October 27, 2020 | K201627 | Dental Computed Tomography X-Ray System, Green X | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| June 16, 2017 | K170066 | Green16/Green18 (Model: PHT-65LHS) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| April 4, 2017 | K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | MUH | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| January 24, 2017 | K163705 | EzRay Air W | EHD | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| October 28, 2016 | K160882 | PaX-i3D Green Premium (Model: PCT-90LH) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| October 20, 2016 | K162660 | Green Smart (Model: PHT-35LHS) | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| September 1, 2016 | K161063 | EzRay Air (Model VEX-P300) | EHD | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| October 23, 2015 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| July 15, 2013 | K130585 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| May 31, 2013 | K130432 | PHT-6500, PHT-60CFO | OAS | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| December 13, 2012 | K123493 | VEX-S 100W INTRAORAL X-RAY SYSTEM | EHD | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| November 20, 2012 | K122606 | PHT-6500; PHT-60CFO; PAX-I3D | OAS | Substantially Equivalent | Mtechgroup | accessdata.fda.gov |
| September 4, 2012 | K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
| March 27, 2012 | K113672 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | VATECH Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Mobile
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Image Processing, Radiological
Updated March 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.