# VATECH Co., Ltd.

- Location (FDA's records): Hwaseong-Si, KR
- FDA decisions: 40 (2008–2026): 40 510(k) clearances
- Product codes: OAS (19), MUH (8), EHD (6), JAK (2), IZL (2), LLZ (1), KPR (1), MQB (1)
- 510(k) review time since 2016: median 63 days, against 92 for FDA's reviews in the same codes and years (9 of 16 faster)
- Predicates its devices cite: 41 (26 its own); citations of its devices by later devices: 44 (26 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- E-Woo Technology: 3 (https://510kreport.com/company/e-woo-technology)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Aribex, Inc.: 2 (https://510kreport.com/company/aribex)
- Mtechgroup: 2 (https://510kreport.com/company/mtechgroup)
- Oehm Und Rehbein GmbH: 1 (https://510kreport.com/company/oehm-und-rehbein)
- Instrumentarium Corp.: 1 (https://510kreport.com/company/instrumentarium)
- Minxray, Inc.: 1 (https://510kreport.com/company/minxray)
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)

## Firms that cite its devices most
- E-Woo Technology: 3 (https://510kreport.com/company/e-woo-technology)
- Rayence Co., Ltd.: 3 (https://510kreport.com/company/rayence)
- Genoray Co., Ltd.: 2 (https://510kreport.com/company/genoray)
- DRTECH Corporation: 1 (https://510kreport.com/company/drtech)
- Durr Dental SE: 1 (https://510kreport.com/company/durr-dental)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)
- Suni Medical Imaging, Inc.: 1 (https://510kreport.com/company/suni-medical-imaging)
- Guangzhou Ajax Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-ajax-medical-equipment)

## Its most-cited devices
- K082350: PAX-500 (2008), cited by 4
- K170066: Green16/Green18 (Model: PHT-65LHS) (2017), cited by 3
- K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart (2015), cited by 3
- K122155: PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray System (2012), cited by 3
- K200182: EzRay Air Portable (Model: VEX-P300) (2020), cited by 3
- K231796: Grreen X 12 (Model: PHT-75CHS) (2023), cited by 2

## Recent decisions
- K260093: Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (Mar 31, 2026)
- K243088: Green X 12 SE  (PHT-40CHS) (Feb 21, 2025)
- K243081: Green X 21  (PHT-90CHO) (Feb 14, 2025)
- 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) (Oct 25, 2024)
- K231796: Grreen X 12 (Model: PHT-75CHS) (Jul 19, 2023)
- K223058: EzRay Air 2 Wall (Model: VEX-S350W) (Oct 26, 2022)
- K213462: EzRay M18 (Model: VMX-P400) (Feb 11, 2022)
- K210329: Green X 18(Model : PHT-75CHS) (Feb 18, 2021)

Source page: https://510kreport.com/company/vatech