• 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.
 
DeviceICAD
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
ICAD, INC.
98 spit brook road
suite 100
nashua, NH 03062
PMA NumberP010038
Supplement NumberS002
Date Received10/28/2002
Decision Date11/20/2002
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A DEVICE NAME CHANGE FROM "MAMMOREADER" TO "ICAD."
-
-