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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 supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS001
Date Received02/13/2003
Decision Date06/30/2003
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the ability of the rapidscreen rs-2000d to process digital images in addition to film/screen images. The device, as modified, will be marketed under the trade name rapidscreen rs-2000d and is indicated for: the rs-2000d is a computer-aided detection (cad) system intended to identify and mark regions of interest (rois) on digital or digitalized 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 the use as an aid only after the physician has performed an initial interpretation of the radiograph.