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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameRAPIDSCREEN RS-2000
Classification Nameanalyzer,medical image
Generic Nameanalyzer, medical image, chest x-ray
ApplicantRIVERAIN MEDICAL GROUP
PMA NumberP000041
Date Received10/10/2000
Decision Date07/12/2001
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 01M-0306
Notice Date 07/23/2001
Advisory Committee Radiology
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
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.
Approval Order Approval Order
Supplements: S001 S002 S003 S005 S006 S009 S010 S011 
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