FDA.reportPublic FDA data

CIRCLE CARDIOVASCULAR IMAGING INC

Matched from indexed company URL: Circle Cardiovascular Imaging Inc.

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#

GUDID#