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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRAPIDSCREEN RS-2000D
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantRiverain Medical Group
3020 S. Tech Blvd.
Miamisburg, OH 45342
PMA NumberP000041
Supplement NumberS005
Date Received07/05/2006
Decision Date11/01/2006
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE RAPIDSCREEN RS-2000D TO PROVIDE REDUCED NUMBER OF FALSE POSITIVES PER IMAGE WITH A STATISTICALLY INSIGNIFICANT IMPACT ON THE DETECTION SENSITIVITY.
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