Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
VATECH Co., Ltd. — Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
310 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | 2026-03-31 | 77 | 0 |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | 2025-02-21 | 144 | 0 |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | 2025-02-14 | 137 | 0 |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (Vi | VATECH Co., Ltd. | 2024-10-25 | 294 | 0 |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | VATECH Co., Ltd. | 2023-07-19 | 29 | 0 |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | VATECH Co., Ltd. | 2022-10-26 | 26 | 0 |
| K213462 | EzRay M18 (Model: VMX-P400) | VATECH Co., Ltd. | 2022-02-11 | 107 | 0 |
| K210329 | Green X 18(Model : PHT-75CHS) | VATECH Co., Ltd. | 2021-02-18 | 14 | 0 |
| K203667 | EzRay M (Model: VMX-P300) | VATECH Co., Ltd. | 2021-02-02 | 48 | 0 |
| K203797 | vatech A9 (Model : PHT-30CSS) | VATECH Co., Ltd. | 2021-01-25 | 28 | 0 |
| K201627 | Dental Computed Tomography X-Ray System, Green X | VATECH Co., Ltd. | 2020-10-27 | 133 | 0 |
| K200182 | EzRay Air Portable (Model: VEX-P300) | VATECH Co., Ltd. | 2020-02-11 | 18 | 0 |
| K170066 | Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. | 2017-06-16 | 158 | 0 |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i | VATECH Co., Ltd. | 2017-04-04 | 25 | 0 |
| K163705 | EzRay Air W | VATECH Co., Ltd. | 2017-01-24 | 26 | 0 |
| K160882 | PaX-i3D Green Premium (Model: PCT-90LH) | VATECH Co., Ltd. | 2016-10-28 | 211 | 0 |
| K162660 | Green Smart (Model: PHT-35LHS) | VATECH Co., Ltd. | 2016-10-20 | 24 | 0 |
| K161063 | EzRay Air (Model VEX-P300) | VATECH Co., Ltd. | 2016-09-01 | 139 | 0 |
| K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D | VATECH Co., Ltd. | 2015-10-23 | 86 | 0 |
| K132983 | TON-95LH, PAX-I3D ORTHO | VATECH Co., Ltd. | 2014-08-07 | 318 | 0 |
| K130585 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITA | VATECH Co., Ltd. | 2013-07-15 | 132 | 0 |
| K130432 | PHT-6500, PHT-60CFO | VATECH Co., Ltd. | 2013-05-31 | 99 | 0 |
| K123493 | VEX-S 100W INTRAORAL X-RAY SYSTEM | VATECH Co., Ltd. | 2012-12-13 | 34 | 0 |
| K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL | VATECH Co., Ltd. | 2012-09-04 | 46 | 0 |
| K121400 | PAX-UNI3D, PHT-7500 | VATECH Co., Ltd. | 2012-08-28 | 110 | 0 |
| K121412 | PAX-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012-06-08 | 28 | 0 |
| K121236 | PAX-DUO3D PLUS, PCT-5000 | VATECH Co., Ltd. | 2012-05-24 | 30 | 0 |
| K113672 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | VATECH Co., Ltd. | 2012-03-27 | 105 | 0 |
| K102078 | RADIOLOGICAL IMAGE PROCESSING SYSTEM | VATECH Co., Ltd. | 2011-08-10 | 380 | 0 |
| K102196 | COMPUTED TOMOGRAPHY X-RAY SYSTEM | VATECH Co., Ltd. | 2011-03-25 | 239 | 0 |
| K102102 | COMPUTED TOMOGRAPHY X-RAY SYSTEM | VATECH Co., Ltd. | 2011-03-11 | 227 | 0 |
| K102259 | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM | VATECH Co., Ltd. | 2011-02-18 | 192 | 0 |
| K101590 | DIGITAL FLAT PANEL X-RAY DETECTOR | VATECH Co., Ltd. | 2010-11-29 | 175 | 0 |
| K102124 | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM | VATECH Co., Ltd. | 2010-10-22 | 85 | 0 |
| K092830 | DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 | VATECH Co., Ltd. | 2010-07-21 | 310 | 0 |
| K100317 | DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO | VATECH Co., Ltd. | 2010-03-24 | 48 | 0 |
| K090467 | DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D | VATECH Co., Ltd. | 2010-01-08 | 319 | 0 |
| K092103 | DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) | VATECH Co., Ltd. | 2009-10-09 | 87 | 0 |
| K082350 | PAX-500 | VATECH Co., Ltd. | 2008-10-10 | 56 | 0 |
| K073365 | DENTAL DIGITAL X-RAY IMAGING SYSTEM | VATECH Co., Ltd. | 2008-04-08 | 130 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda