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Medical equipment and related accessories, software and consumables
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Radiotherapy and radiosurgery instruments
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Radiotherapy treatment planning instruments
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Radiotherapy treatment planning instruments - medical device software
Radiotherapy treatment planning instruments - medical device software
Z11010492
17 devices
Devices
RT Elements - Multiple Brain Mets SRS, 3.0
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
AccuContour
Manteia Technologies Co., Ltd.
·
,
CN
Class IIa
CE/MDR
28620166008
Active
Valid to Jul 2028
FDA 510(k)
K221706
Active
Cleared 9 Mar 2023
+1
authorizations
Mozi Tps
Manteia Technologies Co., Ltd.
·
,
CN
Class IIb
CE/MDR
28620166008
Active
Valid to Jul 2028
FDA 510(k)
K223724
Active
Cleared 10 Jul 2023
RT Elements - RT QA, 3.0
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
RT Elements, 4.6
Brainlab SE
·
,
DE
Class IIb
CE/MDR
AccuContour-Lite
Manteia Technologies Co., Ltd.
·
,
CN
Class IIa
CE/MDR
28620166008
Active
Valid to Jul 2028
GUDID
on market
Ethos Treatment Management
Varian Medical Systems, Inc
·
,
US
Class IIb
FDA 510(k)
K232923
Active
Cleared 30 Apr 2024
CE/MDR
+1
authorizations
RT Elements - Cranial SRS, 3.0
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
ARIA Radiation Therapy Management
Varian Medical Systems, Inc
·
,
US
Class IIb
FDA 510(k)
K173838
Active
Cleared 17 Jan 2018
FDA 510(k)
K242463
Active
Cleared 13 Dec 2024
+3
authorizations
Mria
Manteia Technologies Co., Ltd.
·
,
CN
Class IIa
CE/MDR
28620166008
Active
Valid to Jul 2028
AccuCheck
Manteia Technologies Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K223834
Active
Cleared 20 Jul 2023
FDA 510(k)
K250696
Active
Cleared 24 Oct 2025
+2
authorizations
RT Elements, 4.0
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
RT Elements - Dose Review, 3.0
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
RT Elements - Spine SRS, 3.0
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
Ethos Treatment Management
Varian Medical Systems, Inc.
·
,
US
Class IIb
CE/MDR
GUDID
on market
RT Elements - Cranial SRS w/ Cones, 3.0
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
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