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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 M5000D AND M5000DM, (SOFTWARE VERSION 5.2)
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantR2 TECHNOLOGY, INC.
PMA NumberP970058
Supplement NumberS019
Date Received03/01/2004
Decision Date04/07/2004
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the imagechecker system with the hologic selenia full field digital mammographic system and equivalent private label devices. The device, as modified, will be marketed under the trade names imagechecker m5000d (digital mammography only) and imagechecker m5000dm (digital and analog mammography). The modified device would be supported by software version 5. 2. The indications for use are: the imagechecker m5000d/dm 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 review.
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