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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Radiotherapy and radiosurgery instruments
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Linear accelerators
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Single energy linear accelerators
Single energy linear accelerators
Z11010101
11 devices
Devices
Cyberknife
Accuray Incorporated
·
,
US
Class IIb
CE/MDD
GUDID
on market
SagiStar®
BEBIG Medical GmbH
·
,
DE
Class IIb
CE/MDR
2025-MDR/QS-083/A
Active
Valid to Dec 2030
Radixact
Accuray Incorporated
·
,
US
Class IIb
CE/MDR
CE/MDD
+1
authorizations
Medical Linear Accelerator System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Halcyon
Varian Medical Systems, Inc
·
,
US
Class IIb
FDA 510(k)
K181032
Active
Cleared 9 May 2018
FDA 510(k)
K170817
Active
Cleared 27 Jun 2017
+2
authorizations
Halcyon
Varian Medical Systems, Inc.
·
,
US
Class IIb
CE/MDR
Siddharth-II
Panacea Medical Technologies Pvt Ltd
·
,
IN
Class IIb
CE/MDD
Ethos Radiotherapy System
Varian Medical Systems, Inc.
·
,
US
Class IIb
CE/MDR
GUDID
on market
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