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Accuray Incorporated

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; recall (Z-2640-2026)Accuray Incorporated2026-07-01
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; recall (Z-2644-2026)Accuray Incorporated2026-07-01
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as recall (Z-1023-2025)Accuray Incorporated2025-01-27
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact recall (Z-2489-2023)Accuray Incorporated2023-08-31
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate recall (Z-3211-2018)Accuray Incorporated2018-09-20
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Ro recall (Z-0865-2017)Accuray Incorporated2016-12-21
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 5 recall (Z-0734-2017)Accuray Incorporated2016-12-12
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product recall (Z-0771-2016)Accuray Incorporated2016-02-09
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Co recall (Z-0218-2015)Accuray Incorporated2014-11-14
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indica recall (Z-0828-2014)Accuray Incorporated2014-01-27
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and recall (Z-1155-2013)Accuray Incorporated2013-04-20
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged- recall (Z-1126-2013)Accuray Incorporated2013-04-16
CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Trea recall (Z-1098-2012)Accuray Incorporated2012-02-23
CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife tr recall (Z-0382-2012)Accuray Incorporated2012-01-11
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Tr recall (Z-0035-2012)Accuray Incorporated2011-10-11
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch P recall (Z-0036-2012)Accuray Incorporated2011-10-11
HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System is recall (Z-3108-2011)Accuray Incorporated2011-08-31

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Every clearance here is in the API, with alerts when new ones post.