FDA.reportPublic FDA data

CIRCLE CARDIOVASCULAR IMAGING INC

Matched from indexed company URL: Circle Cardiovascular Imaging

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30073013053007301305CIRCLE CARDIOVASCULAR IMAGING INC1N2026-01-01Suite 1800, 707 8th Avenue SW Calgary Alberta CA T2P 1H5

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
929611833811872K251027cvi42 Coronary Plaque Software ApplicationQIH2025-10-27
929611612402798K250221StrokeSENS ASPECTS Software ApplicationPOK2025-07-01
929611480035448K242781cvi42 Software ApplicationQIH2024-10-15
929611181021622K241038Cardiac CT Function Software ApplicationQIH2024-06-07
929611852420118K232661Myocardial Strain Software ApplicationLLZ2023-12-07
929611893503988K222593TruPlan Computed Tomography (CT) Imaging SoftwareLLZ2023-01-18
929611064250447K213998cvi42 Auto Imaging Software ApplicationQIH2022-07-28
929611685394557K212261StrokeSENS LVOQAS2021-10-14
929611931119880K202212TruPlanLLZ2021-02-19
929612027735440K141480CVI42LLZ2014-08-22
929611152773659K111373CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARELLZ2011-08-23
929611922107965K082628CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23LLZ2008-11-20
929611516633543

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ62023-12-07
QIH42025-10-27
POK12025-07-01
QAS12021-10-14

PMN#

TruPlan

2021-02-19

Circle Cardiovascular Imaging Inc.

CVI42

2014-08-22

CIRCLE CARDIOVASCULAR IMAGING INC

GUDID#

StrokeSENS LVO - StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. StrokeSENS ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and uses an Atlas to segment and analyze ASPECTS Regions. StrokeSENS ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. Theimaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. The StrokeSENS device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.

Circle Cardiovascular Imaging Inc

2025-02-05