# K926321: Varian C/D-Series Clinacs (Clinac 600 C/D)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Aug 9, 1994 after 601 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices 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.

## Most influential descendants
- K082005: Modification to HI-Art Treatment System (2008), 13 descendants of its own
- K112776: Tomotherapy Treatment System Fast Optimizer (2011), 11 descendants of its own
- K121934: Tomotherapy Treatment System (2012), 10 descendants of its own
- K161146: Radixact Treatment Delivery System (2016), 3 descendants of its own
- K161136: Precision Treatment Planning System (2016), 2 descendants of its own

## Recalls of this device
- Aug 14, 2012 · Class II · Z-2383-2012: Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move 
- Nov 28, 2011 · Not classified · Z-0692-2012: An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
- 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/K926321
Methodology: https://510kreport.com/methodology