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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Digital bioimaging management instruments
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Various digital bioimaging management instruments
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Various digital bioimaging management instruments - medical device software
Various digital bioimaging management instruments - medical device software
Z11069092
204 devices
Lumi Prepare
Augmedit B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-8.2.1.4
Active
Valid to Oct 2030
Medical pathology image management software
SenseCare Smart Health Technology Co., Ltd.
·
,
China
Class I
CE/MDR
Synapse Dose
Fujifilm Healthcare Italia S.P.A.
·
,
Italy
Class IIa
CE/MDR
INFINITT DoseM
Infinitt Healthcare Co., Ltd.
·
,
South Korea
Class I
CE/MDR
Connevo Koa
CONNECTEVE Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
Viewer, 5.4
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
System M2
Medirecord CZ s.r.o.
·
,
Czechia
Class I
CE/MDR
Raidas
AIgnostikum GmbH
·
,
Austria
Class IIa
CE/MDR
AI-Rad Companion Chest X-ray
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
Ultima Media Importer
MPTronic
·
,
France
Class I
CE/MDR
Veuron-Brain-pAb
Heuron Co., Ltd.
·
,
South Korea
Class IIa
FDA 510(k)
K203142
Active
Cleared 15 Jan 2021
CE/MDD
+1
authorizations
Tengeer
Gpi S.P.A.
·
,
Italy
Class IIa
CE/MDR
IT321284
Active
Valid to Feb 2028
Ire Mammo Vision
Ire Rayos X, S.A.
·
,
Spain
Class IIa
CE/MDR
Lunit INSIGHT CXR
Lunit Inc.
·
,
South Korea
Class IIa
CE/MDR
Belle 1K
BelleTorus Corporation
·
,
United States
Class I
CE/MDR
Teia
Digitec S.r.l.
·
,
Italy
Class IIa
CE/MDR
StoneChecker
Imaging Biometrics, LLC
·
,
United States
Class I
FDA 510(k)
K191530
Active
Cleared 26 Sep 2019
CE/MDD
AW VolumeShare 7 (version: AW4.7)
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
GUDID
on market
Viewer, 5.3
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
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