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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 SOUTH TECH BLVD.
miamisburg,  OH  45342 -4860
Applicant Contact jennifer v butsch
Correspondent
RIVERAIN MEDICAL GROUP,LLC
3020 SOUTH 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
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