Class Class II

cvi42 Coronary Plaque Software Application (K251027)

K251027 2025-10-27 Traditional
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Description

cvi42 Coronary Plaque Software Application by Circle Cardiovascular Imaging, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251027
Clearance Date2025-10-27
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050

Categories

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