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Accuray Incorporated

USA · Madison

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 2Class III 0

plus 8 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class III 5

10 including historic records

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

4active ARTG entries

IIb 4

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 31 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: Accuray Incorporated · ACCURAY, INC. · ACCURAY INCORPORATED

Business registration

Legal name: ACCURAY INC
CIK: 0001138723
Registration status: Active
Listing status: Listed (ARAY)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11999

12000

12001

12002

12003

22004

22005

22006

22007

22009

12010

32012

32015

32016

22017

12018

12020

12021

12023

FDA listed device types

Accelerator, Linear, Medical 1System, Planning, Radiation Therapy Treatment 1Instrument, Quality-Assurance, Radiologic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223159	Radixact Treatment Delivery System	2023-06-23
US	K212794	Accuray Precision Treatment Planning System	2021-09-30
US	K202412	ClearRT Helical kVCT for the Radixact Treatment Delivery System	2020-12-18
CA	61696	TOMOTHERAPY TREATMENT SYSTEM	Class III
CA	72179	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Class III
CA	85504	CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM	Class III

Accuray Incorporated

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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