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.
 PowerLook 11 2024-06-18
Icad, Inc.
 PowerLook MammoAI Container - Arterys 2024-06-18
Icad, Inc.
 PowerLook MammoAI Container - Sectra 2024-06-18
Icad, Inc.
 PowerLook 10.1.1 2024-06-18
Icad, Inc.
 PowerLook PRO+ 4GPU Tower Platform, OUS 2024-06-18
Icad, Inc.
 TESTING 2024-06-18
Icad, Inc.
 ProFound AI 3.1 2024-06-18
Icad, Inc.
 ProFound AI 3.1 2024-06-18
Icad, Inc.
 PowerLook Density Assessment V4.0 2024-06-18
Icad, Inc.
 TESTING 2024-06-18
Icad, Inc.
 PowerLook AI Mammo Container 1.0.0 Blackford 2024-06-17
Icad, Inc.
 PowerLook PRO+ 4GPU Tower Platform, US 2024-06-17
Icad, Inc.
 PowerLook PRO+ Rack-Mount, US 2024-06-17
Icad, Inc.
 PowerLook PRO+ Rack-Mount, OUS 2024-06-17
Icad, Inc.
 PowerLook PRO+ 2GPU Tower Platform, US 2024-06-17
Icad, Inc.
 PowerLook PRO+, OUS 2024-06-17
Icad, Inc.
 PowerLook 11.1 2024-06-17
Icad, Inc.
 PowerLook MammoAI Container - GE 2024-06-17
Icad, Inc.
 PowerLook Cloud 1.0 2024-06-10
Icad, Inc.
 PowerLook PRO+ 4GPU Tower Platform, OUS 2024-06-10
Icad, Inc.
 PowerLook 11.3 2023-08-10
Icad, Inc.
 PowerLook Cloud 1.0 2023-07-25
Icad, Inc.
 PowerLook 11 PRO+, FRU 2023-07-24
Icad, Inc.
 PowerLook Al Mammo Container - Arterys v 1.2.0 2023-07-24
Icad, Inc.
 PowerLook Al Mammo Container- Ferrum v1.0.0 2023-07-24
Icad, Inc.
 PowerLook Al Mammo Container- Blackford v1.0.0 2023-07-24
Icad, Inc.
 PowerLook Al Mammo Container- GE v1.1.0 2023-07-24
Icad, Inc.
 PowerLook Al Mammo Container - Radiology Partners v1.0.0 2023-07-24
Icad, Inc.
 PowerLook 11.2 2023-07-24
Icad, Inc.
 VeraLook CTC CAD CT-1022021-05-25
Icad, Inc.
 VeraLook CTC CAD CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D702021-05-25
Icad, Inc.
 VeraLook CTC CAD CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D702021-05-25
Icad, Inc.
 PowerLook AMP PRO, SLD, GE, ROW DSC017-04-ROW2021-05-25
Icad, Inc.
 PowerLook AMP PRO, SLD, GE, ROW DSC017-01-ROW2021-05-25
Icad, Inc.
 Powerlook PRO Hardware Upgrade, SLD DSC017-03-ROW2021-05-25
Icad, Inc.
 Powerlook PRO Hardware Upgrade, SLD DSC017-02-ROW2021-05-25
Icad, Inc.
 PowerLook PRO Tomo Detection and SLD, GE DSC014-02-EU2021-05-25
Icad, Inc.
 PowerLook PRO Tomo Detection and SLD, GE DSC014-01-EU2021-05-25
Icad, Inc.
 PowerLook AMP SLD Agfa CR 2021-05-25
Icad, Inc.
 PowerLook AMP SLD Planmed 2021-05-25
Icad, Inc.
 PowerLook AMP SLD Philips OUS 2021-05-25
Icad, Inc.
 PowerLook AMP SLD Giotto 2021-05-25
Icad, Inc.
 PowerLook AMP SLD Hologic OUS 2021-05-25
Icad, Inc.
 PowerLook AMP SLD Fuji OUS 2021-05-25
Icad, Inc.
 PowerLook AMP SLD Siemens OUS 2021-05-25
Icad, Inc.
 PowerLook AMP SLD GE OUS Direct 2021-05-25
Icad, Inc.
 PowerLook AMP SLD GE OUS 2021-05-25
Icad, Inc.
 PowerLook PRO+ 4GPU Tower Upgrade, US 2021-05-25
Icad, Inc.
 PowerLook PRO+ 4GPU Tower Platform, US 2021-05-25
Icad, Inc.
 FRU, PowerLook 10 PRO+ 2021-05-25
Icad, Inc.
 FRU, PowerLook 10, Generic 2021-05-25
Icad, Inc.
 PowerLook 10.1 DSC018-03, DSC018-06, DSC018-03, D4D01802021-05-25
Icad, Inc.
 PowerLook AMP with Density Assessment GE OUS 2021-05-25
Icad, Inc.
 PowerLook AMP with Density Assessment GE US 2021-05-25
Icad, Inc.
 ProFound AI V3.0 2021-05-25
Icad, Inc.
 PowerLook FRU 2021-05-25
Icad, Inc.
 PowerLook PRO+ Rack-Mount, FRU 2021-05-25
Icad, Inc.
 PowerLook PRO+ Rack-Mount, US 2021-05-25
Icad, Inc.
 PowerLook PRO+ Rack-Mount, OUS 2021-05-25
Icad, Inc.
 PowerLook PRO+ Hardware Platform GE, US 2021-05-25
Icad, Inc.
 PowerLook PRO+ Hardware Platform GE 2021-05-25
Icad, Inc.
 PowerLook PRO+ Hardware Platform 2021-05-25
Icad, Inc.
 PowerLook 10 PRO+, Rack Mount, OUS 2021-05-25
Icad, Inc.
 PowerLook 10 PRO+, Rack Mount, US 2021-05-25
Icad, Inc.
 PowerLook 10 PRO+, Tower OUS 2021-05-25
Icad, Inc.
 PowerLook 10 PRO+, Tower US 2021-05-25
Icad, Inc.
 PowerLook 10 PRO+ 2021-05-25
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.
 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 VIEWER2004-11-19
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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.