• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS007
Date Received04/28/2004
Decision Date05/19/2004
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 replacing the icad system's cad software with the second look cad software and increasing the system memory from 1 gigabyte to 2 gigabytes. The device, as modified, will be marketed under the trade name second look 200 and is indicated for: second look is a computed system intended to identify and mark regions of interest on standard mammographic views, including views from patients with breast implants and images from qualified full field digital mammography systems, to bring 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.
-
-