RAPIDSCREEN RS-2000D

FDA Premarket Approval P000041 S005

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.

Pre-market Approval Supplement Details

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.

DeviceRAPIDSCREEN RS-2000D
Generic NameAnalyzer, Medical Image
ApplicantRIVERAIN MEDICAL GROUP
Date Received2006-07-05
Decision Date2006-11-01
PMAP000041
SupplementS005
Product CodeMYN 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address RIVERAIN MEDICAL GROUP 3020 South Tech Blvd. miamisburg, OH 45342-4860

Supplemental Filings

Supplement NumberDateSupplement Type
P000041Original Filing
S011 2012-02-14 Normal 180 Day Track No User Fee
S010 2011-09-02 Normal 180 Day Track
S009 2009-12-10 Normal 180 Day Track
S008
S007
S006 2007-07-26 Normal 180 Day Track No User Fee
S005 2006-07-05 Normal 180 Day Track
S004
S003 2005-11-18 Normal 180 Day Track No User Fee
S002 2003-07-10 Normal 180 Day Track No User Fee
S001 2003-02-13 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
M722XD25114C250640 P000041 000
M722XC25114C250640 P000041 000
M722X25122C250640 P000041 000
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