# K214062: Radialis PET Camera

- Pathway: 510(k) (Traditional)
- Applicant: Radialis, Inc.
- Decided: Feb 4, 2022 after 39 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: 3 generations back to K914267 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090553: Naviscan Pemflex Solo II High Resolution Pet Scanner, Naviscan, Inc. (2009) Summary page 4.

## Indications for use
The Radialis PET Camera is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

Source page: https://510kreport.com/device/K214062
Methodology: https://510kreport.com/methodology