# Circle Cardiovascular Imaging, Inc.

- Location (FDA's records): Calgary, CA
- FDA decisions: 11 (2008–2025): 11 510(k) clearances
- Names in FDA's records: Circle Cardiovascular Imaging, Inc. (9); Circle Cardiovascular Imaging (2)
- Product codes: LLZ (6), QIH (4), POK (1)
- 510(k) review time since 2016: median 152 days, against 141 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 20 (11 its own); citations of its devices by later devices: 23 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medis Medical Imaging Systems BV: 2 (https://510kreport.com/company/medis-medical-imaging-systems)
- Pie Medical Imaging BV: 2 (https://510kreport.com/company/pie-medical-imaging)
- Cleerly, Inc.: 1 (https://510kreport.com/company/cleerly)
- Brainomix Limited: 1 (https://510kreport.com/company/brainomix)
- Vital Images, Inc.: 1 (https://510kreport.com/company/vital-images)
- Ziosoft, Inc.: 1 (https://510kreport.com/company/ziosoft)
- Tomtec Imaging Systems GmbH: 1 (https://510kreport.com/company/tomtec-imaging-systems)

## Firms that cite its devices most
- Cardio Flow Design, Inc.: 2 (https://510kreport.com/company/cardio-flow-design)
- Phantomics, Inc.: 2 (https://510kreport.com/company/phantomics)
- Terarecon,Inc.: 1 (https://510kreport.com/company/terarecon)
- Imbio, LLC: 1 (https://510kreport.com/company/imbio)
- Perspectum, Ltd.: 1 (https://510kreport.com/company/perspectum)
- Mycardium AI Limited: 1 (https://510kreport.com/company/mycardium-ai)
- Artrya Limited: 1 (https://510kreport.com/company/artrya)
- Tribusmed Beheer BV: 1 (https://510kreport.com/company/tribusmed-beheer)

## Its most-cited devices
- K213998: cvi42 Auto Imaging Software Application (2022), cited by 6
- K082628: CMR42 Cardiac Mri Imaging System, 2.1.23 (2008), cited by 5
- K141480: CVI42 (2014), cited by 4
- K111373: CT42 Cardiac Computed Tomography (CT) Software (2011), cited by 3
- K222593: TruPlan Computed Tomography (CT) Imaging Software (2023), cited by 2
- K241038: Cardiac CT Function Software Application (2024), cited by 1

## Recent decisions
- K251027: cvi42 Coronary Plaque Software Application (Oct 27, 2025)
- K250221: StrokeSENS ASPECTS Software Application (Jul 1, 2025)
- K242781: cvi42 Software Application (Oct 15, 2024)
- K241038: Cardiac CT Function Software Application (Jun 7, 2024)
- K232661: Myocardial Strain Software Application (Dec 7, 2023)
- K222593: TruPlan Computed Tomography (CT) Imaging Software (Jan 18, 2023)
- K213998: cvi42 Auto Imaging Software Application (Jul 28, 2022)
- K202212: TruPlan (Feb 19, 2021)

Source page: https://510kreport.com/company/circle-cardiovascular-imaging