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Circle Cardiovascular Imaging, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251027cvi42 Coronary Plaque Software ApplicationOctober 27, 2025
K250221StrokeSENS ASPECTS Software ApplicationJuly 1, 2025
K242781cvi42 Software ApplicationOctober 15, 2024
K241038Cardiac CT Function Software ApplicationJune 7, 2024
K232661Myocardial Strain Software ApplicationDecember 7, 2023
K222593TruPlan Computed Tomography (CT) Imaging SoftwareJanuary 18, 2023
K213998cvi42 Auto Imaging Software ApplicationJuly 28, 2022
K202212TruPlanFebruary 19, 2021
K141480CVI42August 22, 2014
K111373CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWAREAugust 23, 2011
K082628CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23November 20, 2008