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Circle Cardiovascular Imaging, Inc.

Canada · Calgary

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel — 6 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

4listed device types

Class I 0Class II 4Class III 0

plus 12 registration records and 11 510(k)

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

2active device licences

Class II 2

5 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

IIa 4IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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, 11 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 2 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: CIRCLE CARDIOVASCULAR IMAGING INC · CIRCLE CARDIOVASCULAR IMAGING INC.

FDA 510(k) clearances by year

12008

12011

12014

12021

12022

22023

22024

22025

FDA listed device types

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Radiological Computer-Assisted Triage And Notification Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251027	cvi42 Coronary Plaque Software Application	2025-10-27
US	K250221	StrokeSENS ASPECTS Software Application	2025-07-01
US	K242781	cvi42 Software Application	2024-10-15
CA	78347	CMR42 CARDIAC MAGNETIC RESONANCE SOFTWARE APPLICATION	Class II
CA	87520	CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE APPLICATION	Class II

Circle Cardiovascular Imaging, 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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