# K042720: ON-Board Imager Device

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Oct 29, 2004 after 28 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (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.
76 later devices descend from it; 4 cite it directly.
0 of 81 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.

## Most influential descendants
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own
- K123291: Truebeam (2012), 37 descendants of its own
- K123808: Agility (2013), 36 descendants of its own
- K140528: True Beam, True Beam STX, Edge (2014), 31 descendants of its own

## Recalls of this device
- Apr 30, 2014 · Class II · Z-0526-2015: Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc­ tion assembly cable 
- Mar 20, 2014 · Class II · Z-1502-2014: Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
- Jun 21, 2011 · Not classified · Z-3101-2011: Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s.
- 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/K042720
Methodology: https://510kreport.com/methodology