# K251401: PennPET Explorer Positron Emission Tomograph

- Pathway: 510(k) (Traditional)
- Applicant: Trustees of the University of Pennsylvania
- Decided: Nov 25, 2025 after 203 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K930090 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123599: Ingenuity Digital Pet/CT, Philips Healthcare (Cleveland) (2013) Summary page 5.

## Indications for use
The PennPET Explorer PET system is a diagnostic imaging device that, together with the co-located IQon CT scanner, combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The IQon CT system images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET system images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. Together, these systems are used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. The CT scanner can also be operated as fully functional, independent diagnostic tool, including for use in radiation therapy planning.

Source page: https://510kreport.com/device/K251401
Methodology: https://510kreport.com/methodology