Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003873069

FEI Number

3003873069

Entity Name

Accuray Incorporated

City/State/Country

MADISON, WI, US

Establishment Address

1209 DEMING WAY, MADISON, WI 53717, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Accuray Incorporated (Owner Number: 9005157)

Owner / Operator Contact Address

1209 Deming Way, --, Madison, WI 53717, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223159

PMA Number

N/A

All Registered Proprietary Names

CyberKnife Treatment Delivery System CyberKnife S7 CyberKnife M6 TomoTherapy Treatment Delivery System with iDMS CyberKnife M6 Series (FM, FI, FI+, FIM, F Neuro) TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA) CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM Radixact Treatment Delivery System, Accuray Helix (A configuration of Radixact Treatment Delivery System) Accuray Stellar (A configuration of Radixact Treatment Delivery System)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2017-07-13
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2017-08-29
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2015-07-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2016-12-06
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2016-12-06
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2015-07-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-06-27

Official Correspondent

Daniel Biank

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Accuray Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.

Similar Registrations

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3014113695	JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.	Wuxi Jiangsu, CN
1722661	RADIOLOGICAL IMAGING TECHNOLOGY, INC.	Co Spgs, CO, US
3030077501	CHABNER XRT, LLC	Port Chester, NY, US
3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
1932738	MEDTEC LLC	Orange City, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003873069. Last updated year: 2026. Please use registration number 3003873069 when referencing this establishment in official correspondence.