Name: Predicase
Price: 199 USD

K-number	K251401
Device name	PennPET Explorer Positron Emission Tomograph
Applicant	Trustees of the University of Pennsylvania
Product code	KPS
Device class	Class II
Decision date	Nov 25, 2025
Decision	Substantially Equivalent
Regulation	892.1200

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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PennPET Explorer Positron Emission Tomograph

Everything you need for a 510(k) submission. Nothing you don't.