RAPIDSCREEN RS-2000

FDA Premarket Approval P000041

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the rapidscreen(tm) rs-2000. The device is a computer-aided detection (cad) system intended to identify and mark regions of interest (rois) on digitized frontal chest radiographs. It identifies features associated with solitary pulmonary nodules from 9 to 30 mm in size, which could represent early-stage lung cancer. The device is intended for use as an aid only after the physician has performed an initial interpretation of the radiograph.

DeviceRAPIDSCREEN RS-2000
Generic NameAnalyzer, Medical Image
ApplicantRIVERAIN MEDICAL GROUP
Date Received2000-10-10
Decision Date2001-07-12
Notice Date2001-07-23
PMAP000041
SupplementS
Product CodeMYN 
Docket Number01M-0306
Advisory CommitteeRadiology
Expedited ReviewYes
Combination Product No
Applicant Address RIVERAIN MEDICAL GROUP 3020 South Tech Blvd. miamisburg, OH 45342-4860
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.