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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.
 
DevicePARASCRIPT (R) ACCUDETECT (R)
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantParascript, LLC
6273 Monarch Park Pl.
Longmont, CO 80503
PMA NumberP120004
Supplement NumberS001
Date Received01/27/2015
Decision Date10/16/2015
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 PARASCRIPT ACCUDETECT VERSION 7.0.
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