# K211764: Vereos PET/CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 6, 2021 after 59 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: 11 generations back to K930090 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210880: Vereos PET/CT, Philips Medical Systems Nederland B.V. (2021) Summary page 4.

## Indications for use
The Vereos PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The Philips Vereos PET/CT system is used for the purpose 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. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Source page: https://510kreport.com/device/K211764
Methodology: https://510kreport.com/methodology