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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K160882
Device Name PaX-i3D Green Premium (Model: PCT-90LH)
Applicant
VATECH CO., LTD
13, SAMSUNG 1-RO 2-GIL
HWASEONG-SI,  KR 18449
Applicant Contact Daniel Kim
Correspondent
MTECH GROUP
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/31/2016
Decision Date 10/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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