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regulatory

Leading the Cardiovascular Imaging Industry

Circle Improves patient outcome by revolutionizing the cardiovascular healthcare industry through innovation, and enabling healthcare providers to complete effective and precise analysis.

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Clearances

American flag, red and white stripes, blue field with white stars.
Canadian flag: red bars on either side of a white square with a red maple leaf in the center.
Australian flag: blue background with Union Jack and white stars.
Australian flag: blue background with Union Jack and white stars.
Malaysian flag: blue field with yellow crescent and star, red and white stripes.
Flag of Singapore: Red upper half with white crescent and five stars; white bottom half.
Japanese flag: white background with large red circle in the center.
Taiwan's flag: a red field with a blue canton bearing a white sunburst emblem.
South Korean flag: white background with a central yin-yang symbol and four trigrams.
Indian flag: saffron, white, and green horizontal stripes with navy blue wheel in the center.
Flag of El Salvador, blue and white horizontal stripes, national emblem centered.
Chinese flag: red field with five yellow stars.

  • China

    cvi42


    NMPA Approved

Flag of Brazil: green background, yellow diamond, blue circle with stars and
Flag of the United Arab Emirates: red vertical stripe at left, green, white, and black horizontal stripes.
Flag of Thailand: five horizontal stripes, red-white-blue-white-red.
Red and white horizontal bicolor flag, Indonesia's national flag.
Flag of Argentina: blue-white-blue horizontal stripes with a golden sun in the center.
Saudi Arabia flag: green field with white Arabic script and a sword below.
Flag of Colombia, featuring horizontal bands of yellow, blue, and red.
Chile's flag: a blue square with a white star in the upper-left, white and red stripes.
South African flag: red, white, green, blue, yellow, and black design with horizontal bands and a central Y shape.
Israeli flag: white field with a blue Star of David, and two blue horizontal stripes.

  • Israel

    cvi42


    25830055


    StrokeSENS


    25830062

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WATCHMAN TruPlan Clearances

Access information related to WATCHMAN TruPlan, including user manuals and clearances.

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Quality Policy

Circle endeavors to constantly innovate and improve our cardiovascular and neurovascular imaging software by clearly understanding the ever-changing needs and requirements of physicians worldwide. We strive to serve them with clinical tools that provide for the best possible outcomes.

Through adherence to and improvement of our Quality Management System we continuously strive to be the leader in our industry, providing value added products for healthcare institutions worldwide. We are guided by our core values of quality, innovation, people, and customers.

To achieve this Circle will: 

  • Ensure that our product and quality management system is effective and in compliance with the applicable standards and regulations;
  • Ensure that the quality objectives are established and reviewed;
  • Ensure that the products we design, develop, and manufacture meet their stated or implied specifications;
  • Understand the requirements of our customers and address their relevant concerns; and
  • Involve employees at all levels of the organization.
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Environmental, Social, and Governance

Circle Cardiovascular Imaging, as a Software as a Medical Device (SaMD) company that operates in many countries globally, strives to create environments that enhance the lives of our customers and employees, but a changing world brings both uncertainty and opportunities.

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Compliance Information

Circle Cardiovascular Imaging Inc. holds globally recognized ISO 13485:2016 and MDSAP certificates from the British Standards Institution (BSI). In addition to ISO 13485:2016 and MDSAP, the company quality system is established and maintained in alignment with global medical device regulations, including European Medical Device Regulation (EU) 2017/745, Australian Therapeutic Goods (Medical Devices) Regulations, U.S. FDA Quality Management System Regulation (QMSR) - 21 CFR Part 820. Circle continues to monitor regulatory developments and updates its quality system as required to ensure ongoing compliance with evolving global regulatory requirements.



Circle’s software development process incorporates several internationally recognized standards and guidance documents, including: BS EN (IEC) 62304:2006+A1:2015, BS EN (IEC) 62366-1:2015+A1:2020, and IEC 82304-1:2016. An intensive risk management process, based on BS EN (ISO) 14971:2019+A11:2021, is also implemented as part of the development process, to capture the potential harms, hazards, and hazardous situations, and to mitigate these identified risks.


If you require further information on Circle's Quality System or the regulatory approval status for Circle products, please contact the following:


Dr. Shirantha Samarappuli
Vice President
Regulatory Affairs and QMS


Email: shirantha.samarappuli@circlecvi.com
Phone: +1 (587) 747-4692

BSI ISO 13485:2016 Certificate # FM 539204 (Effective: Aug 31st, 2024)
BSI ISO 13485:2016 Certificate # MDSAP 689664 (Effective: Aug 31st, 2024)

BSI ISO 13485 certification mark with EU REP and Australian sponsor details.
Computer screen displaying medical imaging of a heart, showing various views and analyses of internal structures.

AI Plaque Analysis

AI-powered coronary plaque quantification with detailed reporting - fully interactive and integrated into your CT workflow.