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Circle Cardiovascular Imaging, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest Approval2025-10-27
TypeNumberDevice NameCodeDate
510(k) K251027 cvi42 Coronary Plaque Software Application QIH 2025-10-27 View
510(k) K250221 StrokeSENS ASPECTS Software Application POK 2025-07-01 View
510(k) K242781 cvi42 Software Application QIH 2024-10-15 View
510(k) K222593 TruPlan Computed Tomography (CT) Imaging Software LLZ 2023-01-18 View
510(k) K213998 cvi42 Auto Imaging Software Application QIH 2022-07-28 View
510(k) K202212 TruPlan LLZ 2021-02-19 View
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