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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 K133797
Device Name QMASTER-H/REVO
Applicant
Telesystems Co., Ltd.
110 E. Granada Blvd.
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
Telesystems Co., Ltd.
110 E. Granada Blvd.
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/13/2013
Decision Date 09/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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