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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
Devices
Raygenic Rayspad
Onwelo Sp. z o.o.
·
,
PL
Class IIa
CE/MDR
Lte-Nano-100
Vertice Helathcare (Pty) Ltd
·
,
ZA
Class IIb
CE/MDR
XploreView Web
EDL (Edition et Développement de Logiciels)
·
,
FR
Class IIa
CE/MDD
Medis Suite MRCT
Medis Medical Imaging Systems bv
·
,
NL
Class IIa
CE/MDD
e-ASPECTS
Brainomix Limited
·
,
GB
Class IIa
CE/MDD
Virtual Expert
Cercare Medical A/S
·
,
DK
Class IIb
CE/MDR
GUDID
on market
TeraRecon Neuro
Terarecon Inc.
·
,
US
Class IIa
CE/MDD
GUDID
on market
SwiftMR
AIRS Medical Inc.
·
,
KR
Class IIa
CE/MDR
SCAR-23.2.1.0
Active
Valid to Jan 2029
FDA 510(k)
K253775
Active
Cleared 26 Mar 2026
+4
authorizations
Brainomix 360 e-CTA
Brainomix Limited
·
,
GB
Class IIb
CE/MDR
Oncology Virtual Expert
Cercare Medical A/S
·
,
DK
Class IIa
CE/MDR
CT Eye
Oxipit, UAB
·
,
LT
Class IIb
CE/MDR
Brainomix 360 e-ASPECTS
Brainomix Limited
·
,
GB
Class IIb
CE/MDR
LVO Occlusion Detection
Cercare Medical A/S
·
,
DK
Class IIb
CE/MDR
ICH Bleeding Detection
Cercare Medical A/S
·
,
DK
Class IIb
CE/MDR
Brainomix 360 e-CTA
Brainomix Limited
·
,
GB
Class IIb
FDA 510(k)
K192692
Active
Cleared 28 May 2020
FDA 510(k)
K242123
Active
Cleared 6 Jan 2025
+1
authorizations
Rayscape
Mindfully Technologies SRL
·
,
RO
Class I
CE/MDD
Brainomix 360 e-ASPECTS
Brainomix Limited
·
,
GB
Class IIb
CE/MDR
Nexus DR
Varex Imaging Corporation
·
,
US
Class IIb
CE/MDR
e-ASPECTS
Brainomix Limited
·
,
GB
Class IIa
CE/MDR
HAI-RadX Suite
Harrison-Ai Medical Pty Ltd
·
,
AU
Class IIb
CE/MDR
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