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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.
 
DeviceCLEARREAD DETECT
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
RIVERAIN MEDICAL GROUP
3020 south tech blvd.
miamisburg, OH 45342-4860
PMA NumberP000041
Supplement NumberS010
Date Received09/02/2011
Decision Date11/08/2011
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the onguard 5. 2. 1 computer aided detection software.
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