Icad Inc

FDA Filings

This page includes the latest FDA filings for Icad Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQICADDUNS 108870254
FDA Registration(s)
Registration Number1225671
FEI Number3001451447
NameiCAD, Inc.
Owner & OperatorICAD INC.
Contact Address98 SPIT BROOK ROAD, SUITE 100 --
Nashua NH 03062 US
Official Correspondent
  • Heather A Reed
  • x-603-8825200-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4 Townsend West, Suite 9
Nashua, NH 03063 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



Registration Number3005594788
FEI Number3005594788
NameXOFT, A Subsidiary of iCAD
Owner & OperatorICAD INC.
Contact Address98 SPIT BROOK ROAD, SUITE 100 --
Nashua NH 03062 US
Official Correspondent
  • Heather A Reed
  • x-603-8825200-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address101 Nicholson Ln
San Jose, CA 95134 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
ICAD Inc.
ProFound AI Software V3.02021-03-12
Icad, Inc.
Balloon Applicator AB20712019-11-13
Icad, Inc.
Balloon Applicator AB20702019-11-13
Icad, Inc.
Balloon Applicator AB2073E2019-11-13
Icad, Inc.
Balloon Applicator AB20722019-11-13
iCAD, Inc. [ICAD INC.]
ProFound AI V2.12019-10-09
Icad, Inc.
PowerLook 2019-10-07
Icad, Inc.
PowerLook 2019-10-07
ICAD Inc.
ProFound AI Software V2.12019-10-04
Icad, Inc.
ProFound AI 2019-07-19
Icad, Inc.
PowerLook Tomo Detection (ProFound AI) 2019-07-12
Icad, Inc.
DynaCAD D4D01852019-05-23
Icad, Inc.
DynaLOC Breast Interventional Planning Software D75014-05, D57015-052019-05-23
Icad, Inc.
Packaged Cutout set,xFlex F5410-KIT2019-02-21
Icad, Inc.
Packaged Cutout 33mm, xFlex F5410-332019-02-21
Icad, Inc.
Packaged Cutout 30mm, xFlex F5410-302019-02-21
Icad, Inc.
Packaged Cutout 27 mm, xFlex F5410-272019-02-21
Icad, Inc.
Packaged Cutout 25 mm, xFlex F5410-252019-02-21
Icad, Inc.
Packaged Cutout 22.2 mm, xFlex F5410-222019-02-21
Icad, Inc.
Packaged Cutout 17.5 mm, xFlex F5410-172019-02-21
Icad, Inc.
Packaged Cutout 15 mm, xFlex F5410-152019-02-21
Icad, Inc.
Packaged Cutout 12.7 mm, xFlex F5410-122019-02-21
Icad, Inc.
xFlexShield F54102019-02-21
Icad, Inc.
Flexishield Radiation Absorber F52012019-02-21
Icad, Inc.
Rigid Shield 7 cm F5350-72019-02-21
Icad, Inc.
Rigid Shield 6 cm F5350-62019-02-21
Icad, Inc.
Rigid Shield 5 cm F5350-52019-02-21
Icad, Inc.
Rigid Shield 4 cm F5350-42019-02-21
Icad, Inc.
Axxent Radiation Shield - Rigid F53502019-02-21
Icad, Inc.
Rigid Shield 3 cm F5350-32019-02-21
iCAD, Inc. [ICAD INC.]
ProFound AI2018-12-11
iCAD, Inc. [ICAD INC.]
PowerLook Tomo Detection V2.02018-12-11
ICAD Inc.
PowerLook Tomo Detection V2 Software2018-12-06
Icad, Inc.
PowerLook Density Assessment V3.4 D70141, D70142, D701602018-08-06
Icad, Inc.
VeraLook CTC CAD CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D702018-07-06
Icad, Inc.
PowerLook PRO with Tomo Detection DSC014-03-US2018-07-06
Icad, Inc.
Powerlook PRO with SLD, FRU D4D01922018-07-06
Icad, Inc.
Powerlook PRO with SLD, GE, US DSC017-04-US2018-07-06
Icad, Inc.
PowerLook to PowerLook PRO Upgrade, US DSC017-03-US2018-07-06
Icad, Inc.
Powerlook PRO Hardware Upgrade, SLD DSC017-02-US2018-07-06
Icad, Inc.
PowerLook Tomo Detection and SecondLook Digital License D701332018-07-06
Icad, Inc.
iReveal with PowerLook AMP DSC0122018-07-06
Icad, Inc.
Surface Applicator Cone, 50 mm SK10502018-07-06
Icad, Inc.
Surface Applicator Cone, 35 mm SK10352018-07-06
Icad, Inc.
Surface Applicator Cone, 20 mm SK10202018-07-06
Icad, Inc.
Surface Applicator Cone, 10 mm SK10102018-07-06
Icad, Inc.
PowerLook AMP PRO with SecondLook Digital DSC017-01-US2018-07-06
Icad, Inc.
Surface Applicator Set SK10002018-07-06
Icad, Inc.
Cervical Applicator Set CG10002018-07-06
Icad, Inc.
Cervical Applicator Set, Bundle 2 CG10022018-07-06
Icad, Inc.
Cervical Applicator Set, Bundle 1 CG10012018-07-06
Icad, Inc.
Axxent Surface Controller XP12002018-07-06
Icad, Inc.
Axxent Standard Controller XP11002018-07-06
Icad, Inc.
Vaginal Applicator, 35mm AG30352018-07-06
Icad, Inc.
Vaginal Applicator, 30mm AG30302018-07-06
Icad, Inc.
Vaginal Applicator, 25mm AG30252018-07-06
Icad, Inc.
Vaginal Applicator, 20mm AG30202018-07-06
Icad, Inc.
Vaginal Applicator Set AG30002018-07-06
Icad, Inc.
Vaginal Applicator Set with Base and Clamp AG30102018-07-06
Icad, Inc.
(10) Applicator End Cap, 50 mm SK35502018-07-06
Icad, Inc.
(10) Applicator End Cap, 35 mm SK35352018-07-06
Icad, Inc.
(10) Applicator End Cap, 20 mm SK35202018-07-06
Icad, Inc.
(10) Applicator End Cap, 10 mm SK35102018-07-06
Icad, Inc.
Surface Applicator Set Bundle 1 SK10012018-07-06
Icad, Inc.
Balloon Applicator Kit AB2063E2018-07-06
Icad, Inc.
Balloon Applicator Kit AB20622018-07-06
Icad, Inc.
Balloon Applicator Kit AB20612018-07-06
Icad, Inc.
Balloon Applicator Kit AB20602018-07-06
Icad, Inc.
HDR X-ray Source 2.2 S75512018-07-06
Icad, Inc.
HDR X-ray Source 2.2 S76012018-07-06
Icad, Inc.
HDR X-ray Source 2.2 S75012018-07-06
Icad, Inc.
PowerLook PRO Tomo Detection FRU D4D01812018-07-06
Icad, Inc.
PowerLook PRO with Tomo Detection, Upgrade, GE DSC014-02-US2018-07-06
Icad, Inc.
PowerLook PRO Tomo Detection and SLD, GE DSC014-01-US2018-07-06
Icad, Inc.
PowerLook Tomo Detection Software DS0244, D701302018-07-06
Icad, Inc.
iReveal Breast Density Assessment D70124, D70141 and D701262018-07-06
Icad, Inc.
PowerLook AMP SLD FRU GE 2376858-8-US2018-07-06
Icad, Inc.
PowerLook AMP SLD FRU D4D01472018-07-06
Icad, Inc.
PowerLook AMP SLD Philips DSC010-07-US2018-07-06
Icad, Inc.
PowerLook AMP SLD Hologic DSC010-05-US2018-07-06
Icad, Inc.
PowerLook AMP SLD Fuji DSC010-04-US2018-07-06
Icad, Inc.
PowerLook AMP SLD Siemens DSC010-03-US2018-07-06
Icad, Inc.
PowerLook AMP SLD GE Direct DSC010-12-US2018-07-06
Icad, Inc.
PowerLook AMP SLD GE US DSC010-01-US2018-07-06
Icad, Inc.
SecondLook Digital (SLD) DS02062018-07-06
iCAD, Inc. [ICAD INC.]
PowerLook Breast Assessment v3.42018-06-27
ICAD, Inc
PowerLook Density Assessment Software2018-04-05
iCAD, Inc. [ICAD INC.]
PowerLook Tomo Detection2017-03-31
ICAD Inc
PowerLook® Tomo Detection Software2017-03-24
ICAD, INC.
M-VU ALGORITHM ENGINE2017-01-11
XOFT, A Subsidiary of iCAD [ICAD INC.]
Surface Controller2016-10-12
ICAD INC.
Axxent Electronic Brachytherapy System Model 110 XP 12002016-02-25
iCAD, Inc. [ICAD INC.]
PowerLook Density Assessment2015-06-09
XOFT, A Subsidiary of iCAD [ICAD INC.]
eFlex, Flexishield2015-05-27
ICAD, INC.
M-VU ALGORITHM ENGINE2015-03-02
ICAD, INC.
AXXENT CERVICAL APPLICATOR2014-09-05
ICAD, INC.
M-VU ALGORITHM ENGINE2014-06-06
ICAD, INC.
M-VU ALGORITHM ENGINE2013-12-02
ICAD, INC.
M-VU ALGORITHM ENGINE2013-06-19
ICAD, INC.
SECONDLOOK DIGITAL2013-06-19
XOFT, A Subsidiary of iCAD [ICAD INC.]
Axxent Controller2013-04-05
XOFT, A Subsidiary of iCAD [ICAD INC.]
Axxent Cervical Applicator2013-04-04
ICAD, INC.
XOFT AXXENT CERVICAL APPLICATORS2013-02-27
ICAD, INC.
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 1102013-01-17
ICAD, INC.
SECONDLOOK DIGITAL V7.2 CAD2012-11-09
ICAD, INC.
M-VU ALGOIRITHM ENGINE2012-10-01
ICAD, INC.
VERSAVUE ENTERPRISE SUITE2012-07-20
ICAD, INC.
M-VU ALGORITHM ENGINE2012-01-23
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT RADIATION SHIELD - RIGID2011-11-22
iCAD, Inc. [ICAD INC.]
PowerLook AMP2011-11-08
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT BALLOON APPLICATOR2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT FLEXISHIELD MINI2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT SURFACE APPLICATOR2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT VAGINAL APPLICATOR2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM2011-02-25
ICAD, INC.
SECONDLOOK (SL) CAD2010-12-07
iCAD, Inc. [ICAD INC.]
VeraLook Colon CAD2010-08-19
ICAD, INC.
ICAD VERALOOK CTC CAD SOFTWARE2010-08-04
ICAD, INC.
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D700242009-03-31
ICAD, INC.
SECONDLOOK (SL) CAD2008-10-09
iCAD, Inc. [ICAD INC.]
Howtek 9602008-04-24
ICAD, INC.
SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM2008-04-04
iCAD, Inc. [ICAD INC.]
SecondLook2007-12-05
ICAD, INC.
SECONDLOOK2007-07-27
ICAD, INC.
SECOND LOOK2006-01-13
ICAD, INC.
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM2005-03-07
ICAD, INC.
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM2004-09-01
ICAD, INC.
ICAD SYSTEM2004-05-21
ICAD, INC.
ICAD SYSTEM2004-05-19
ICAD, INC.
ICAD SYSTEM2003-10-31
ICAD, INC.
ICAD SYSTEM2003-10-10
ICAD, INC.
ICAD2003-03-06
ICAD, INC.
ICAD2003-02-24
ICAD, INC.
ICAD2002-11-20
ICAD, INC.
SECOND LOOK2002-01-15

Related Finance Registrations
NCAGE Code3CHX4ICAD INC.!DBA QUALIA COMPUTING INC.
NCAGE Code73X38ICAD, INC.!DBA USE CAGE CODE 0N9X5 FOR!CATALOGING!DIV ICAD
CAGE Code0N9X5ICAD, INC. ICAD
CAGE Code3CHX4ICAD INC. QUALIA COMPUTING INC.
CAGE Code73X38ICAD, INC. USE CAGE CODE 0N9X5 FOR CATALOGING ICAD
S.A.M. Registration0N9X5 [108870254]ICAD, INC.
DUNS799838065ICAD INC.
SEC0000749660ICAD INC of DELAWARE
SEC0000827198ICAD INC
SEC749660ICAD INC of DELAWARE

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