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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.
 
Trade NameIMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantR2 TECHNOLOGY, INC.
PMA NumberP970058
Supplement NumberS017
Date Received07/08/2003
Decision Date11/25/2003
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a new digitizer, the vidar diagnostic pro film digitizer and new cad software, version 6. 0. The device, as modified, will be marketed under the trade name imagechecker lx and imagechecker dx depending upon options chosen. The indications are: the imagechecker lx/dx is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second view.
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