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Circle Cardiovascular Imaging, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K251027 cvi42 Coronary Plaque Software ApplicationQIH2025-10-27 View
510(k) K250221 StrokeSENS ASPECTS Software ApplicationPOK2025-07-01 View
510(k) K242781 cvi42 Software ApplicationQIH2024-10-15 View
510(k) K222593 TruPlan Computed Tomography (CT) Imaging SoftwareLLZ2023-01-18 View
510(k) K213998 cvi42 Auto Imaging Software ApplicationQIH2022-07-28 View
510(k) K202212 TruPlanLLZ2021-02-19 View
510(k) K111373 CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARELLZ2011-08-23 View
510(k) K082628 CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23LLZ2008-11-20 View
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