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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K111776
Device Name DELTAVIEW MODEL 2.1
Applicant
Riverain Medical Group,Llc
3020 S. Tech Blvd.
Miamisburg,  OH  45342 -4860
Applicant Contact JENNIFER V BUTSCH
Correspondent
Riverain Medical Group,Llc
3020 S. Tech Blvd.
Miamisburg,  OH  45342 -4860
Correspondent Contact JENNIFER V BUTSCH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/23/2011
Decision Date 12/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT01261507
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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