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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K143560
Device Name CygneX I System
Applicant
Accuthera, Inc.
2-8-22 Kurigi, Asaoku
Kawasaki,  JP 215-0033
Applicant Contact Eiji Tanabe
Correspondent
Quality and Regulatory Services, Inc.
1244 Fairway Valley Ct.
Lincoln,  CA  95648
Correspondent Contact Robert J. Morton
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/16/2014
Decision Date 10/05/2015
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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