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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
Brainomix 360 e-CTA
Brainomix Limited
·
,
United Kingdom
Class IIb
CE/MDR
RadiSpine
Radirad Co., Ltd.
·
,
Taiwan
Class I
CE/MDR
RBfracture
Radiobotics ApS
·
,
Denmark
Class IIa
CE/MDR
Enterprise Archive v8
GE Healthcare
·
,
United States
Class I
CE/MDR
Venus Explorer
Softway Medical
·
,
France
Class IIa
CE/MDR
e-CTA
Brainomix Limited
·
,
United Kingdom
Class IIa
CE/MDD
Milvue Suite
Milvue
·
,
France
Class IIa
CE/MDR
VEA Align
Eos Imaging
·
,
France
Class IIa
FDA 510(k)
×3
K123740
Active
Cleared 22 Feb 2013
CE/MDR
+1
authorizations
Radiation Dose Monitor (RDM)
MPTronic
·
,
France
Class I
CE/MDR
FloyBrain
Floy GmbH
·
,
Germany
Class IIb
CE/MDR
SCAR-7.2.1.5
Active
Valid to Sep 2030
Nexus DRF
Varex Imaging Corporation
·
,
United States
Class IIb
CE/MDR
GUDID
on market
FloySpine CT
Floy GmbH
·
,
Germany
Class IIb
CE/MDR
Starviewer 2.0
Institut De Diagnostic Per La Imatge
·
,
Spain
Class IIa
CE/MDR
LVO Occlusion Detection
Cercare Medical A/S
·
,
Denmark
Class IIb
CE/MDR
TeraRecon Neuro
Terarecon Inc.
·
,
United States
Class IIa
FDA 510(k)
K220349
Active
Cleared 12 Aug 2022
CE/MDR
FloyMammo
Floy GmbH
·
,
Germany
Class IIa
CE/MDR
SCAR-7.2.1.5
Active
Valid to Sep 2030
OsiriX MD
Pixmeo Sàrl
·
,
Switzerland
Class IIa
FDA 510(k)
K101342
Active
Cleared 20 Aug 2010
CE/MDD
Brainomix 360 e-ASPECTS
Brainomix Limited
·
,
United Kingdom
Class IIb
CE/MDR
e-ASPECTS
Brainomix Limited
·
,
United Kingdom
Class IIa
CE/MDD
MSK Eye
Oxipit, UAB
·
,
Lithuania
Class IIb
CE/MDR
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