# K250170: Pharos

- Pathway: 510(k) (Traditional)
- Applicant: Brightonix Imaging
- Decided: Aug 15, 2025 after 206 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: 2 generations back to K091269 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210450: BBX-PET Scanner, Prescient Imaging, LLC (2021) Summary page 5.

## Indications for use
PHAROS is a dedicated PET scanner intended to obtain Positron Emission Tomography (PET) images of parts of human body that fit in the patient aperture (brain, breast, arms and legs) to detect abnormal patterns of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in diagnosis, therapeutic planning and therapeutic outcome assessment.

Source page: https://510kreport.com/device/K250170
Methodology: https://510kreport.com/methodology