FDA.reportPublic FDA data

ICAD INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30269708823026970882ICAD INC.1N2026-01-012 Townsend West Suite 6 Nashua NH US 03063
12256713001451447iCAD, Inc.1N2020-04-254 Townsend West, Suite 9 Nashua NH US 03063

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
915321722851553P160009PowerLook® Tomo Detection SoftwareMYN2017-03-24
3158281722851553P160009PowerLook® Tomo Detection SoftwareMYN2017-03-24
915321230689067P010038SECOND LOOKMYN2002-01-15
3158281230689067P010038SECOND LOOKMYN2002-01-15
915321556064553K970908HOWTEK 960LMA1997-05-20
3158281556064553K970908HOWTEK 960LMA1997-05-20
3158281215483879K240417ProFound Detection (V4.0)QDQ2024-11-08
3158282027077658K211506PowerLook Density Assessment V4.0QIH2021-07-12
3158281788614383K203822ProFound AI Software V3.0QDQ2021-03-12
915321274702012K191994ProFound AI Software V2.1QDQ2019-10-04
3158281274702012K191994ProFound AI Software V2.1QDQ2019-10-04
915321699911152K182373PowerLook Tomo Detection V2 SoftwareQDQ2018-12-06
3158281699911152K182373PowerLook Tomo Detection V2 SoftwareQDQ2018-12-06
915321548729328K180125PowerLook Density Assessment SoftwareLLZ2018-04-05
3158281548729328K180125PowerLook Density Assessment SoftwareLLZ2018-04-05
3158281323716527K132742M-VU BREAST DENSITYLLZ2013-12-03
915321323716527K132742M-VU BREAST DENSITYLLZ2013-12-03
3158281469438794K091529ICAD VERALOOK CTC CAD SOFTWAREJAK2010-08-04
915321469438794K091529ICAD VERALOOK CTC CAD SOFTWAREJAK2010-08-04
915321228314567
3158281228314567

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QDQ62024-11-08
LLZ42018-04-05
MYN42017-03-24
JAK22010-08-04
LMA21997-05-20
QIH12021-07-12

PMA#

ICAD

2003-03-06

ICAD, INC.

ICAD

2003-02-24

ICAD, INC.

ICAD

2002-11-20

ICAD, INC.

PMN#

GUDID#

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