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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K131428
Device Name RADVISION
Applicant
Acoustic Medsystems, Inc.
208 Burwash Ave.
Savoy,  IL  61874
Applicant Contact JENNIFER WILLIAMS
Correspondent
Acoustic Medsystems, Inc.
208 Burwash Ave.
Savoy,  IL  61874
Correspondent Contact JENNIFER WILLIAMS
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
KXK  
Date Received05/17/2013
Decision Date 07/16/2013
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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