# K913119: Varian C-Series Clinacs (Clinac 2300C/D)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Nov 7, 1991 after 115 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
89 later devices descend from it; 2 cite it directly.
0 of 90 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
- K033343: Trilogy Radiotherapy Delivery System (2003), 87 descendants of its own
- K061140: Trilogy Radiotherapy Delivery System (2006), 86 descendants of its own
- K070094: Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System (2007), 78 descendants of its own
- K072916: Trilogy System with Rapidarc (2007), 77 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own

## 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 
- Oct 8, 2009 · Not classified · Z-0910-2011: Product may deliver radiation treatment to areas larger than intended,to healthy tissue.
- May 2, 2007 · Not classified · Z-1074-2007: The wedge tray may slip out of the Clinac interface mount during gantry rotation.
- Aug 31, 2006 · Not classified · Z-0194-2007: The chain holding the device gantry in position may break.
- 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.

Source page: https://510kreport.com/device/K913119
Methodology: https://510kreport.com/methodology