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510(k) K251401

PennPET Explorer Positron Emission Tomograph by Trustees of the University of Pennsylvania — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2025
Date Received
May 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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