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FDA 510(k)

PennPET Explorer Positron Emission Tomograph

K-Number: K251401 · 2025-11-25

ApplicantTrustees of the University of Pennsylvania
Decision Date2025-11-25
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PennPET Explorer Positron Emission Tomograph is a medical device manufactured by Trustees of the University of Pennsylvania. It received FDA 510(k) clearance on 2025-11-25 under approval number K251401. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PennPET Explorer Positron Emission Tomograph?

PennPET Explorer Positron Emission Tomograph is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Trustees of the University of Pennsylvania. The 510(k) number is K251401.

When was PennPET Explorer Positron Emission Tomograph approved by the FDA?

PennPET Explorer Positron Emission Tomograph received FDA 510(k) clearance on 2025-11-25, under approval number K251401.

What company makes PennPET Explorer Positron Emission Tomograph?

PennPET Explorer Positron Emission Tomograph is manufactured by Trustees of the University of Pennsylvania.

What is the FDA product code for PennPET Explorer Positron Emission Tomograph?

The FDA product code for PennPET Explorer Positron Emission Tomograph is KPS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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