# K052325: Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

- Pathway: 510(k) (Special)
- Applicant: Accuray Incorporated
- Decided: Sep 14, 2005 after 20 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 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 no predicate by number.

## Most influential descendants
- K082775: Prescision Option (2009), 9 descendants of its own
- K090683: Syngo RT Therapist Connect (2009), 7 descendants of its own
- K102671: Syngo RT Therapist Connect Workspace, V4.2 (2010), 5 descendants of its own
- K103606: Artiste Solution with Sys_VB50 Update (2011), 4 descendants of its own
- K092145: 160MLC Option (2009), 4 descendants of its own

## Recalls of this device
- Mar 21, 2007 · Not classified · Z-0364-2008: Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.

## Indications for use
The CyberKnife System is 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/K052325
Methodology: https://510kreport.com/methodology