# K170788: CyberKnife Treatment Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorportaed
- Decided: Apr 11, 2017 after 26 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K150873 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150873: CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System, Accuray Incorporated (2015) Summary page 5.

## Recalls of this device
- Jun 16, 2026 · Class II · Z-2640-2026: In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using
- Jun 16, 2026 · Class II · Z-2644-2026: In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using
- Dec 23, 2024 · Class II · Z-1023-2025: Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damag
- Feb 26, 2021 · Class II · Z-1272-2021: The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.

## Indications for use
The CyberKnife® Treatment Delivery System is indicated for 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/K170788
Methodology: https://510kreport.com/methodology