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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 K122606
Device Name PHT-6500; PHT-60CFO; PAX-I3D
Applicant
MTECH GROUP
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Applicant Contact DAVE KIM
Correspondent
MTECH GROUP
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number892.1750
Classification Product Code
OAS  
Date Received08/27/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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