# K023052: Acuity Radiation Therapy Simulator

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 11, 2002 after 28 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K853349 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964138: Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software, Varian Medical Systems, Inc. (1997) Summary page 2.

## Most influential descendants
- K033339: Acuity with Conebeam Computed Tomography (2003), 0 descendants of its own

## Recalls of this device
- Nov 23, 2005 · Not classified · Z-0393-06: The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.

## Indications for use
The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied.

Source page: https://510kreport.com/device/K023052
Methodology: https://510kreport.com/methodology