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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.
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
3020 south tech blvd.
miamisburg, OH 45342-4860
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S005 S006 S009 S010 S011