# K041519: Modification to: on-Board Imager Device

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Aug 4, 2004 after 58 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963624 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040192: ON-Board Imager Device, Varian Medical Systems, Inc. (2004) Summary page 1.

## Recalls of this device
- Jan 3, 2008 · Not classified · Z-1442-2008: If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
- Apr 18, 2007 · Not classified · Z-1195-2007: Patient positioning errors may occur because of mechanical variations during product installation.

## Indications for use
The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

Source page: https://510kreport.com/device/K041519
Methodology: https://510kreport.com/methodology