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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.
 
DeviceONGUARD
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantRiverain Medical Group
3020 S. Tech Blvd.
Miamisburg, OH 45342
PMA NumberP000041
Supplement NumberS009
Date Received12/10/2009
Decision Date06/10/2010
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Clinical TrialsNCT00906789
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 THE ONGUARD 5.1 CADE SOFTWARE.
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