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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-CTP/e-MRI
Brainomix Limited
·
,
United Kingdom
Class IIb
CE/MDR
Sim&Size
Sim&Cure
·
,
France
Class IIa
CE/MDD
GUDID
on market
Virtual Expert
Cercare Medical A/S
·
,
Denmark
Class IIb
CE/MDR
GUDID
on market
Centricity Enterprise Archive v4.0
GE Healthcare
·
,
United States
Class I
CE/MDR
TeraRecon Cardiovascular.Calcification.CT
Terarecon Inc.
·
,
United States
Class IIa
FDA 510(k)
K250288
Active
Cleared 23 Oct 2025
CE/MDR
Join
Allm Inc.
·
,
Japan
Class I
CE/MDD
Brainomix 360 e-CTA
Brainomix Limited
·
,
United Kingdom
Class IIb
CE/MDR
Brainomix 360 e-Lung
Brainomix Limited
·
,
United Kingdom
Class IIb
FDA 510(k)
×2
K242411
Active
Cleared 19 Feb 2025
CE/MDR
ICH Bleeding Detection
Cercare Medical A/S
·
,
Denmark
Class IIb
CE/MDR
Nexus DRF
Varex Imaging Corporation
·
,
United States
Class IIb
CE/MDR
GUDID
on market
Radimetrics® Enterprise Application
Bayer Medical Care Inc.
·
,
United States
Class I
CE/MDR
GUDID
on market
ICH Bleeding Detection
Cercare Medical A/S
·
,
Denmark
Class IIb
CE/MDR
Virtual Expert
Cercare Medical A/S
·
,
Denmark
Class IIb
CE/MDR
GUDID
on market
LVO Occlusion Detection
Cercare Medical A/S
·
,
Denmark
Class IIb
CE/MDR
Alma WORKSTATION
Alma IT Systems, S.L.
·
,
Spain
Class IIa
CE/MDD
e-CTP
Brainomix Limited
·
,
United Kingdom
Class IIa
CE/MDD
StrokeViewer
Nicolab B.V.
·
,
Netherlands
Class IIb
FDA 510(k)
K231570
Active
Cleared 14 Dec 2023
CE/MDR
SwiftMR
AIRS Medical Inc.
·
,
South Korea
Class IIa
CE/MDR
SCAR-23.2.1.0
Active
Valid to Jan 2029
GUDID
on market
TomoCon PACS
TatraMed Software s.r.o.
·
,
Slovakia
Class IIb
CE/MDD
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