Class Class II

HESTIA (K243420)

K243420 2025-07-17 Traditional
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Description

HESTIA by Genoray Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243420
Clearance Date2025-07-17
Clearance TypeTraditional
Product CodeMUE
Regulation Number892.1715

Categories

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