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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Radiology instruments
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Radiology instruments - medical device software
Radiology instruments - medical device software
Z11030592
103 devices
SpectoMED
Specto Medical
·
,
Switzerland
Class IIa
CE/MDR
GUDID
on market
Brainomix 360 e-CTP/e-MRI
Brainomix Limited
·
,
United Kingdom
Class IIb
CE/MDR
RBfracture
Radiobotics ApS
·
,
Denmark
Class IIa
CE/MDR
RBfracture
Radiobotics ApS
·
,
Denmark
Class IIa
CE/MDR
e-CTA
Brainomix Limited
·
,
United Kingdom
Class IIa
CE/MDD
HAI-RadX Suite
Harrison-Ai Medical Pty Ltd
·
,
Australia
Class IIb
CE/MDR
Brainomix 360 e-ASPECTS
Brainomix Limited
·
,
United Kingdom
Class IIb
FDA 510(k)
×2
K243294
Active
Cleared 14 Feb 2025
CE/MDR
Galileo
Milvue
·
,
France
Class IIa
CE/MDR
RBfracture
Radiobotics ApS
·
,
Denmark
Class IIa
CE/MDR
XploreView
EDL (Edition et Développement de Logiciels)
·
,
France
Class IIa
CE/MDD
Brainomix 360 e-CTP/e-MRI
Brainomix Limited
·
,
United Kingdom
Class IIb
FDA 510(k)
×2
K231656
Active
Cleared 30 Aug 2023
CE/MDR
Centricity RIS-i 7.0.x
GE Healthcare
·
,
United States
Class I
CE/MDR
FloyBoneClassification
Floy GmbH
·
,
Germany
Class IIb
CE/MDR
SCAR-7.2.1.5
Active
Valid to Sep 2030
Brainomix 360 e-ASPECTS
Brainomix Limited
·
,
United Kingdom
Class IIb
CE/MDR
MammoScape
Mevis Medical Solutions AG
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
TeraRecon Aorta.CT
Terarecon Inc.
·
,
United States
Class IIa
CE/MDR
FloyOsteo
Floy GmbH
·
,
Germany
Class IIb
CE/MDR
SCAR-7.2.1.5
Active
Valid to Sep 2030
Sim&Size
Sim&Cure
·
,
France
Class IIa
FDA 510(k)
×6
K190049
Active
Cleared 17 Sep 2019
CE/MDR
+1
authorizations
Sim&Size
Sim&Cure
·
,
France
Class IIa
CE/MDR
GUDID
on market
Alma CLINIC
Alma IT Systems, S.L.
·
,
Spain
Class IIa
CE/MDD
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