# K212606: BeamSite

- Pathway: 510(k) (Special)
- Applicant: Doseoptics, LLC
- Decided: Sep 15, 2021 after 29 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K901932 (1991). 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)
- K200940: BeamSite, Doseoptics, LLC (2020) Summary page 4.

## Indications for use
The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.

Source page: https://510kreport.com/device/K212606
Methodology: https://510kreport.com/methodology