Cleared Traditional

PennPET Explorer Positron Emission Tomograph

K251401 · Trustees of the University of Pennsylvania · Radiology

Nov 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K251401 is an FDA 510(k) clearance for the PennPET Explorer Positron Emission Tomograph, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Trustees of the University of Pennsylvania (Philadelphia, US). The FDA issued a Cleared decision on November 25, 2025, 203 days after receiving the submission on May 6, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number	K251401 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2025
Decision Date	November 25, 2025
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF