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510(k) K253844

AnyScan 3.0 NM Scanner Family by Mediso Medical Imaging Systems, Ltd. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2025
Date Received
December 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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