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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 M1000
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantR2 TECHNOLOGY, INC.
PMA NumberP970058
Supplement NumberS012
Date Received02/05/2002
Decision Date02/11/2002
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the new efficacy claim in pma supplement 7 (version 2. 2 software). The change is from: "for every 100,000 cancers currently detected by screening mammography, the use of the imagechecker could result in early detection of an additional 30,500 breast cancers. " to: "use of the imagechecker could result in earlier detection of up to 23. 4% (95% ci, 19. 4% - 27. 4%) of the cancers currently detected with screening mammography in those women who had a prior screening mammogram 9-24 months earlier. ".
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