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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K121109
Device Name AERODR X70
Applicant
Konica Minolta Medical & Graphic, Inc.
# 1 Sakura-Machi, Hino-Shi
Tokyo,  JP 191-8511
Applicant Contact SHIGEYUKI KOJIMA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number892.1680
Classification Product Code
KPR  
Date Received04/12/2012
Decision Date 05/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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