CyberKnife Treatment Delivery System

510(k) K170788

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK170788	Date11 Apr 2017Cleared	StatusActive

4 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-2644-2026 FDA Class II initiated 16 Jun 2026
- Ongoing Z-2640-2026 FDA Class II initiated 16 Jun 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 the in-room control pendant, the collimator may release and fall from the housing.
- Completed Z-1023-2025 FDA Class II initiated 23 Dec 2024
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 damaged.
- Terminated Z-1272-2021 FDA Class II initiated 26 Feb 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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)