Chrysalis Intelligence · Sponsors · Accuray Incorporated

Accuray Incorporated

Madison, WI, US · 3 510(k) clearances · 7 recalls

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Total clearances
3
2020-12-18 → 2023-06-23
Last 12 months
0
Product codes
1
Most recent
2023-06-23
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYE Accelerator, Linear, Medical Class II Radiology 3 2023-06-23
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
2
Most recent
2026-06-16
DateSeverityStatusRecall # ProductCodeReason
2026-06-16 Class II Ongoing Z-2644-2026 Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator — 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 …
2026-06-16 Class II Ongoing Z-2640-2026 Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator — 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 …
2024-12-23 Class II Completed Z-1023-2025 CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM R… — 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 …
2023-08-03 Class II Completed Z-2489-2023 Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. — It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for mo…
2021-02-26 Class II Terminated Z-1272-2021 CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision… — The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
2020-12-10 Class II Terminated Z-0785-2021 TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and preci… — "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
2020-12-10 Class II Terminated Z-0784-2021 TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radi… — "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2023-06-23 K223159 Radixact Treatment Delivery System IYE Class II Radiology
2021-09-30 K212794 Accuray Precision Treatment Planning System IYE Class II Radiology
2020-12-18 K202412 ClearRT Helical kVCT for the Radixact Treatment Delivery System IYE Class II Radiology
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence