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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 K123526
Device Name CLEARREAD +CONFIRM
Applicant
RIVERAIN TECHNOLOGIES
3020 SOUTH TECH BLVD.
MIAMISBURG,  OH  45324
Applicant Contact JENNIFER BUTSCH
Correspondent
RIVERAIN TECHNOLOGIES
3020 SOUTH TECH BLVD.
MIAMISBURG,  OH  45324
Correspondent Contact JENNIFER BUTSCH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/15/2012
Decision Date 12/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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