FDA 510(k)

PennPET Explorer Positron Emission Tomograph

K-Nummer: K251401 · 2025-11-25

AntragstellerTrustees of the University of Pennsylvania

Entscheidungsdatum2025-11-25

ProduktcodeKPS

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: KPS)

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