Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantICAD, INC.
98 SPIT BROOK ROAD
SUITE 100
NASHUA, NH 03062
PMA NumberP010038
Supplement NumberS009
Date Received01/18/2005
Decision Date03/07/2005
Reclassified Date 02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR PRIVATE LABEL DISTRIBUTION (HOLOGIC, INC. TO DISTRIBUTE SECOND LOOK). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECURLOOK AND IS INDICATED FOR: THE SECURLOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC 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 OF THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
-
-