# K971839: Varian Radiation Therapy Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Aug 15, 1997 after 88 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901932 (1991). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901932: Varian Electronic Portal Imaging System, Varian Assoc., Inc. (1991) Summary page 1.

## Most influential descendants
- K091209: Portalvision Advanced Imaging (2009), 2 descendants of its own
- K200940: BeamSite (2020), 1 descendant of its own
- K212606: BeamSite (2021), 0 descendants of its own

## Indications for use
RTIS is an imaging accessory indicated for use with radiotherapy devices such as linear accelerators and simulators. It provides rediographic/fluoroscopic images for simulations, and portal images for high energy treatment machines.

Source page: https://510kreport.com/device/K971839
Methodology: https://510kreport.com/methodology