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510(k) K243420

HESTIA by Genoray Co., Ltd. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2025
Date Received
November 4, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full Field Digital, System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1715
Review Panel
RA
Submission Type

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