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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 NameCLEAREAD DETECT
Classification Nameanalyzer,medical image
Generic Nameanalyzer, medical image, chest x-ray
ApplicantRIVERAIN MEDICAL
PMA NumberP000041
Supplement NumberS011
Date Received02/14/2012
Decision Date02/27/2012
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to market the device under the additional trade name clearread detect.
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