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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K251401
Device Name PennPET Explorer Positron Emission Tomograph
Applicant
Trustees of the University of Pennsylvania
5th Floor, Franklin Bldg.
3451 Walnut St.
Philadelphia,  PA  19104 -6205
Applicant Contact Joel Karp
Correspondent
Trustees of the University of Pennsylvania
5th Floor, Franklin Bldg.
3451 Walnut St.
Philadelphia,  PA  19104 -6205
Correspondent Contact Joel Karp
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/06/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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