Class Class II

CAC (gated) Algorithm (K240369)

K240369 2024-09-27 Traditional
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Description

CAC (gated) Algorithm by BunkerHill Health, an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240369
Clearance Date2024-09-27
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750

Categories

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