Class Class II

Caption Interpretation Automated Ejection Fraction Software (DEN220063)

DEN220063 2023-02-24 Direct
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Description

Caption Interpretation Automated Ejection Fraction Software by Caption Health, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN220063
Clearance Date2023-02-24
Clearance TypeDirect
Product CodeQVD
Regulation Number892.2055

Categories

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