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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
35 crosby dr.
bedford, MA 01730
PMA NumberP970058
Supplement NumberS018
Date Received10/22/2003
Decision Date11/26/2003
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the imagechecker system with the fischer imaging's senoscan full field digital mammography system. The device, as modified, will be marketed under the trade names imagechecker d (digital mammography only), imagechecker dm (digital and analog mammography), and imagechecker oem-d (digital mammography only, sold by ffdm vendor). The modified device would be supported by software version 5. 1. The indications for use are: the imagechecker d/dm. Oem-d 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.