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Icad, Inc.

USA · Nashua

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 1Class II 6Class III 0

plus 12 registration records and 14 510(k), 31 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 5

14 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 14 510(k), 31 PMA, 1 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: ICAD INC. · ICAD, INC.

FDA 510(k) clearances by year

12004

12009

12010

12012

22013

12014

12016

22018

12019

22021

12024

FDA listed device types

Automated Radiological Image Processing Software 1System, Image Processing, Radiological 1Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer 1System, X-Ray, Tomography, Computed 1Digitizer, Image, Radiological 1Analyzer, Medical Image 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240417	ProFound Detection (V4.0)	2024-11-08
US	K211506	PowerLook Density Assessment V4.0	2021-07-12
US	K203822	ProFound AI Software V3.0	2021-03-12
CA	65463	SECOND LOOK 400	Class II
CA	65461	SECOND LOOK DIGITAL	Class II
CA	80024	TOTALLOOK MAMMOADVANTAGE	Class II

Icad, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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