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510(k) K230800

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 by GEMSS HEALTHCARE CO., LTD. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2023
Date Received
March 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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