SECOND LOOK

Analyzer, Medical Image

FDA Premarket Approval P010038 S010

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.

Pre-market Approval Supplement Details

Approval for a manufacturing site located at infumedics, inc. , east walpole, massachusetts.

DeviceSECOND LOOK
Classification NameAnalyzer, Medical Image
Generic NameAnalyzer, Medical Image
ApplicantICAD, INC.
Date Received2005-10-18
Decision Date2006-01-13
PMAP010038
SupplementS010
Product CodeMYN
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonExpress Gmp Supplement
Expedited ReviewNo
Combination Product No
Applicant Address ICAD, INC. 98 Spit Brook Road suite 100 nashua, NH 03062

Supplemental Filings

Supplement NumberDateSupplement Type
P010038Original Filing
S017 2012-10-05 Normal 180 Day Track
S016 2012-08-10 Normal 180 Day Track
S015 2008-05-19 Normal 180 Day Track No User Fee
S014 2007-04-02 Normal 180 Day Track No User Fee
S013 2006-12-18 Normal 180 Day Track
S012 2006-07-12 Normal 180 Day Track
S011
S010 2005-10-18 Normal 180 Day Track No User Fee
S009 2005-01-18 Normal 180 Day Track No User Fee
S008 2004-06-24 Normal 180 Day Track
S007 2004-04-28 Real-time Process
S006 2004-04-26 Normal 180 Day Track No User Fee
S005 2003-07-29 Normal 180 Day Track
S004 2003-06-18 Normal 180 Day Track
S003 2003-02-10 Normal 180 Day Track
S002 2002-10-28 Real-time Process
S001 2002-10-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00858012005007 P010038 012
00858012005830 P010038 013
00858012005823 P010038 013
00858012005809 P010038 013
00858012005175 P010038 013
00858012005168 P010038 013
00858012005151 P010038 013
00858012005144 P010038 013
00858012005137 P010038 013
00858012005120 P010038 013
00858012005113 P010038 013
00858012005106 P010038 013
00858012005847 P010038 013
00858012005861 P010038 013
00858012005014 P010038 013
00858012005854 P010038 013
00858012005816 P010038 013
00858012005793 P010038 013
00858012005601 P010038 013
00858012005083 P010038 013
00858012005076 P010038 013
00858012005052 P010038 013
00858012005038 P010038 013
00858012005021 P010038 013
00858012005090 P010038 013
00858012005069 P010038 016
00858012005045 P010038 017
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