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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 NameICAD SYSTEM
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system
ApplicantICAD, INC.
PMA NumberP010038
Supplement NumberS005
Date Received07/30/2003
Decision Date10/31/2003
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 1) an upgraded algorithm for the icad system, 2) use of the icad system directly with images obtained on the fischer senoscan ffdm system, and 3) the new inclusion of women with breast implants in the target population in the indications for use (ifu). The device, as modified, will be marketed under the trade name icad system with the following indications for use: the icad is a computer system intended to identify and mark regions of interest on standard mammographic views, including views from cases for patients with breast implants and images from qualified full field digital mammography systems, 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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