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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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Radiotherapy simulation instruments
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Instruments for radiotherapy simulation - medical device software
Instruments for radiotherapy simulation - medical device software
Z11010292
7 devices
Devices
EBS Preoperative planning software
Ekliptik razvoj in svetovanje d.o.o.
·
,
SI
Class I
CE/MDD
Mediq RT
Synaptiq Technologies SRL
·
,
RO
Class IIa
CE/MDR
Workspace+
Mvision AI Oy
·
,
FI
Class IIa
CE/MDR
InterVapor® Personalized Procedure Program (IP3®)
Uptake Medical Technologies, Inc.
·
,
US
Class IIb
CE/MDD
MVision Segmentation Service
Mvision AI Oy
·
,
FI
Class I
FDA 510(k)
K241490
Active
Cleared 18 Oct 2024
FDA 510(k)
K212915
Active
Cleared 3 May 2022
+3
authorizations
Dose+
Mvision AI Oy
·
,
FI
Class IIa
FDA 510(k)
K250064
Active
Cleared 4 Sep 2025
CE/MDR
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