# K102650: Cyberknife Robotic Radiosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Nov 17, 2010 after 64 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CyberKnife System: named in the summary without a submission number

## Most influential descendants
- K140528: True Beam, True Beam STX, Edge (2014), 31 descendants of its own
- K143224: TrueBeam-TrueBeam STx-Edge (2014), 25 descendants of its own
- K162472: TrueBeam-TrueBeam STx-Edge (2017), 23 descendants of its own
- K170817: Halcyon (2017), 15 descendants of its own
- K181032: Halcyon (2018), 14 descendants of its own

## Recalls of this device
- Sep 12, 2011 · Not classified · Z-0035-2012: A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly.
- Sep 12, 2011 · Not classified · Z-0036-2012: A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent o

## Indications for use
The CyberKnife® Robotic Radiosurgery System and CyberKnife VSI~ Robotic Radiosurgery System are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K102650
Methodology: https://510kreport.com/methodology