CIRCLE CARDIOVASCULAR IMAGING INC

FDA Device Registration & Listing · Calgary Alberta, CA · Registration 3007301305

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007301305
FEI Number
3007301305
Entity Name
CIRCLE CARDIOVASCULAR IMAGING INC
City/State/Country
Calgary Alberta, CA
Establishment Address
Suite 1800, 707 8th Avenue SW, Calgary Alberta T2P 1H5, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Circle Cardiovascular Imaging Inc (Owner Number: 10026988)
Owner / Operator Contact Address
Suite 1800 707 8th Avenue SW, Calgary, CA-AB T2P 1H5, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250221
PMA Number
N/A

All Registered Proprietary Names

StrokeSENS LVO CVI42 CVI42 TruPlan CVI42 cvi42 cmr42 cvi42 StrokeSENS ASPECTS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2023-10-04
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-12-12
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-10-30
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-10-30
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-02-25
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-11-02
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-11-02
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2008-11-24
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2014-11-20
POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer Radiology Class 2 892.2060 2025-07-07

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Randall Business: ComplianceAcuity, Inc Email: info@complianceacuity.com Phone: (303) 8280844

Related Public Records

Same Entity

Circle Cardiovascular Imaging Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K220709 Aidoc Medical , Ltd. BriefCase 2022-10-07
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007301305. Last updated year: 2026. Please use registration number 3007301305 when referencing this establishment in official correspondence.
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