Cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inc
CIRCLE CARDIOVASCULAR IMAGING INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007301305 | 3007301305 | CIRCLE CARDIOVASCULAR IMAGING INC | 1 | N | 2026-01-01 | Suite 1800, 707 8th Avenue SW Calgary Alberta CA T2P 1H5 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 92961 | 1833811872 | K251027 | cvi42 Coronary Plaque Software Application | QIH | 2025-10-27 |
| 92961 | 1612402798 | K250221 | StrokeSENS ASPECTS Software Application | POK | 2025-07-01 |
| 92961 | 1480035448 | K242781 | cvi42 Software Application | QIH | 2024-10-15 |
| 92961 | 1181021622 | K241038 | Cardiac CT Function Software Application | QIH | 2024-06-07 |
| 92961 | 1852420118 | K232661 | Myocardial Strain Software Application | LLZ | 2023-12-07 |
| 92961 | 1893503988 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | LLZ | 2023-01-18 |
| 92961 | 1064250447 | K213998 | cvi42 Auto Imaging Software Application | QIH | 2022-07-28 |
| 92961 | 1685394557 | K212261 | StrokeSENS LVO | QAS | 2021-10-14 |
| 92961 | 1931119880 | K202212 | TruPlan | LLZ | 2021-02-19 |
| 92961 | 2027735440 | K141480 | CVI42 | LLZ | 2014-08-22 |
| 92961 | 1152773659 | K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | LLZ | 2011-08-23 |
| 92961 | 1922107965 | K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | LLZ | 2008-11-20 |
| 92961 | 1516633543 |
Product Codes Associated With Registrations#
PMN#
TruPlan
Circle Cardiovascular Imaging Inc.
CVI42
CIRCLE CARDIOVASCULAR IMAGING INC
CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
CIRCLE CARDIOVASCULAR IMAGING INC.
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
CIRCLE CARDIOVASCULAR IMAGING INC.
GUDID#
cvi42 - 6.x
2024-01-15
TruPlan - 3.x
2023-01-23
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.
2025-02-05
TruPlan - 2.1
2022-10-20
TruPlan - 1.x
2021-03-01
cvi42 - Cardiac MR & CT imaging software application
2017-07-28
cvi42 - 5.x
2019-05-06
cvi42 - Cardiac MR & CT imaging software application
2017-07-28