510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Vatech Co., Ltd.

Hwaseong-si Gyeonggi, KR

VATECH CO., LTD. appears in FDA device records in Hwaseong-si Gyeonggi, KR. FDA records list 40 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
40
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 40 510(k) clearances for Vatech Co., Ltd. between 2008 and 2026. The busiest year on record is 2012, with 6. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vatech Co., Ltd., by decision year
YearClearances
20082
20091
20105
20114
20126
20132
20141
20151
20163
20173
20202
20213
20222
20231
20241
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OASSubstantially Equivalent
K243088Green X 12 SE (PHT-40CHS)OASSubstantially Equivalent
K243081Green X 21 (PHT-90CHO)OASSubstantially Equivalent
K240040VistaPano 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)MUHSubstantially Equivalent
K231796Grreen X 12 (Model: PHT-75CHS)OASSubstantially Equivalent
K223058EzRay Air 2 Wall (Model: VEX-S350W)EHDSubstantially Equivalent
K213462EzRay M18 (Model: VMX-P400)IZLSubstantially Equivalent
K210329Green X 18(Model : PHT-75CHS)OASSubstantially Equivalent
K203667EzRay M (Model: VMX-P300)IZLSubstantially Equivalent
K203797vatech A9 (Model : PHT-30CSS)OASSubstantially Equivalent
K201627Dental Computed Tomography X-Ray System, Green XOASSubstantially Equivalent
K200182EzRay Air Portable (Model: VEX-P300)EHDSubstantially Equivalent
K170066Green16/Green18 (Model: PHT-65LHS)OASSubstantially Equivalent
K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightMUHSubstantially Equivalent
K163705EzRay Air WEHDSubstantially Equivalent
K160882PaX-i3D Green Premium (Model: PCT-90LH)OASSubstantially Equivalent
K162660Green Smart (Model: PHT-35LHS)OASSubstantially Equivalent
K161063EzRay Air (Model VEX-P300)EHDSubstantially Equivalent
K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartOASSubstantially Equivalent
K132983TON-95LH, PAX-I3D ORTHOOASSubstantially Equivalent
K130585PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUHSubstantially Equivalent
K130432PHT-6500, PHT-60CFOOASSubstantially Equivalent
K123493VEX-S 100W INTRAORAL X-RAY SYSTEMEHDSubstantially Equivalent
K122155PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUHSubstantially Equivalent
K121400PAX-UNI3D, PHT-7500OASSubstantially Equivalent
K121412PAX-FLEX3D, PHT-7000OASSubstantially Equivalent
K121236PAX-DUO3D PLUS, PCT-5000OASSubstantially Equivalent
K113672PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUHSubstantially Equivalent
K102078RADIOLOGICAL IMAGE PROCESSING SYSTEMLLZSubstantially Equivalent
K102196COMPUTED TOMOGRAPHY X-RAY SYSTEMOASSubstantially Equivalent
K102102COMPUTED TOMOGRAPHY X-RAY SYSTEMJAKSubstantially Equivalent
K102259DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEMJAKSubstantially Equivalent
K101590DIGITAL FLAT PANEL X-RAY DETECTORMQBSubstantially Equivalent
K102124DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEMMUHSubstantially Equivalent
K092830DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000KPRSubstantially Equivalent
K100317DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMOMUHSubstantially Equivalent
K090467DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3DOASSubstantially Equivalent
K092103DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)EHDSubstantially Equivalent
K082350PAX-500OASSubstantially Equivalent
K073365DENTAL DIGITAL X-RAY IMAGING SYSTEMMUHSubstantially Equivalent

Registered establishments

FDA registered establishments for Vatech Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30047063133004706313VATECH CO., LTD.13, Samsung 1-ro, 2-gil, Hwaseong-si Gyeonggi 18449 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain