# K904364: Varian C-Series Clinacs Clinac 600C,2100C,2500C

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Feb 27, 1991 after 156 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 23, 2010 · Not classified · Z-1249-2011: Position errors may result in misdelivery of radiation.
- Jun 10, 2010 · Not classified · Z-0886-2011: The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with 
- 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.
- May 29, 2009 · Not classified · Z-1729-2009: Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.
- 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.
- Mar 30, 2005 · Not classified · Z-1530-05: Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.
- Feb 4, 2005 · Not classified · Z-0777-05: Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

Source page: https://510kreport.com/device/K904364
Methodology: https://510kreport.com/methodology