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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 NameIMAGE CHECKER M1000 SYSTEM
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantR2 TECHNOLOGY, INC.
PMA NumberP970058
Supplement NumberS016
Date Received05/08/2003
Decision Date09/10/2003
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 a new software release (v5. 0) that: 1) provides the user with a choice of two operating points (one with higher sensitivity and increased false marks and the other with lower false marks with decreased sensitivity, chosen at the time of device installation) for use with film/screen images only; 2) when packaged with v3. 1a software in a single image checker housing, allows the processing of both analog and ge ffdm images; 3) allows cad processing of ge ffdm dicom images formatted for presentation; and 4) reduces the number of oversized malignant calcification clusters missed by earlier algorithms.
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