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 the device name listed in this FDA 510(k) record. The listed applicant is Trustees of the University of Pennsylvania. It received FDA 510(k) clearance on 2025-11-25 under 510(k) 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. The listed applicant is Trustees of the University of Pennsylvania. The 510(k) number is K251401.

When did PennPET Explorer Positron Emission Tomograph receive FDA 510(k) clearance?

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

Who is the listed applicant for PennPET Explorer Positron Emission Tomograph?

The FDA 510(k) record lists Trustees of the University of Pennsylvania as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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