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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRAPIDSCREEN RS-2000D
Classification Nameanalyzer,medical image
Generic Nameanalyzer, medical image, chest x-ray
ApplicantRIVERAIN MEDICAL
PMA NumberP000041
Supplement NumberS005
Date Received07/10/2006
Decision Date11/01/2006
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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