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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
Genki Edge
Deeptek Medical Imaging Private Limited
·
,
India
Class I
CE/MDR
WebScribe View
O3 Enterprise srl
·
,
Italy
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
Aview
Coreline Soft Co., Ltd.
·
,
South Korea
Class IIb
FDA 510(k)
×4
K171199
Active
Cleared 31 Oct 2018
CE/MDR
Carpl
CARPL.ai Inc.
·
,
United States
Class I
FDA 510(k)
K232891
Active
Cleared 27 Mar 2024
CE/MDR
+1
authorizations
eRis/eVisit
Exprivia S.p.A.
·
,
Italy
Class IIa
CE/MDR
VUNO Med-DeepBrain
VUNO Inc.
·
,
South Korea
Class IIa
FDA 510(k)
K231398
Active
Cleared 4 Oct 2023
CE/MDR
+1
authorizations
Synapse Mobility
ResolutionMD Inc.
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Brainlab Elements – Trajectory Planning, 2.6
Brainlab SE
·
,
Germany
Class IIb
FDA 510(k)
K223552
Active
Cleared 19 Apr 2023
CE/MDR
+1
authorizations
QP-Brain®
Quibim S.L.
·
,
Spain
Class IIa
FDA 510(k)
K232231
Active
Cleared 13 Dec 2023
CE/MDR
+1
authorizations
Lumi Referenced
Augmedit B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-8.2.1.4
Active
Valid to Oct 2030
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
Brainlab Elements Contouring, 5.0
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Ultima DICOM Converter
MPTronic
·
,
France
Class I
CE/MDR
BriefCase-Quantification
Aidoc Medical Ltd
·
,
Israel
Class IIa
FDA 510(k)
×5
K241112
Active
Cleared 15 May 2024
CE/MDR
+1
authorizations
DS Core Detect
Zetta25 AG
·
,
Switzerland
Class IIa
CE/MDR
GUDID
on market
Emaging Suite~emaging Core
Eurochimica srl
·
,
Italy
Class I
CE/MDR
Lunit INSIGHT MMG
Lunit Inc.
·
,
South Korea
Class IIa
FDA 510(k)
K211678
Active
Cleared 17 Nov 2021
CE/MDR
+1
authorizations
eViewer
Exprivia S.p.A.
·
,
Italy
Class IIa
CE/MDR
PIUR tUS inside
piur imaging GmbH
·
,
Austria
Class IIa
CE/MDR
24M00155SUP03
Active
Valid to Feb 2030
FDA 510(k)
K250484
Active
Cleared 30 Jun 2025
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