# K033339: Acuity with Conebeam Computed Tomography

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 30, 2003 after 74 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K853349 (1985). 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)
- K023052: Acuity Radiation Therapy Simulator, Varian Medical Systems, Inc. (2002) Summary page 1.
- K981056: Varian Ximatron Scan Vision CT, Varian Medical Systems, Inc. (1998) Summary page 1.

## Recalls of this device
- Apr 19, 2010 · Not classified · Z-1003-2011: The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
- Aug 11, 2008 · Not classified · Z-0117-2009: During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers.
- Jan 3, 2008 · Not classified · Z-1460-2008: Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a trea

## 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 irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.

Source page: https://510kreport.com/device/K033339
Methodology: https://510kreport.com/methodology