# K862645: Clinac (R) C Series (400C, 600C, 2100C, 2500C)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Oct 3, 1986 after 84 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (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
- May 2, 2007 · Not classified · Z-1074-2007: The wedge tray may slip out of the Clinac interface mount during gantry rotation.
- Jun 6, 2006 · Not classified · Z-1206-06: Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
- 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/K862645
Methodology: https://510kreport.com/methodology