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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
Synapse Workflow Es
Fujifilm Healthcare Italia S.P.A.
·
,
Italy
Class I
CE/MDR
Xeleris 4 DR Processing and Review Workstation
GE Hualun Medical Systems Co., Ltd
·
,
China
Class IIa
CE/MDD
DS Core Diagnosis
Zetta25 AG
·
,
Switzerland
Class IIa
CE/MDR
GUDID
on market
Spine Planning, 1.0
Brainlab SE
·
,
Germany
Class IIb
CE/MDD
GUDID
on market
Blackford Accept Reject Tool
Blackford Analysis Limited
·
,
United Kingdom
Class I
CE/MDR
Xeleris V Processing & Review System
GE Medical Systems Israel, Functional Imaging
·
,
Israel
Class IIa
CE/MDD
FDA 510(k)
K201103
Active
Cleared 25 Sep 2020
+2
authorizations
Ire Image Channel
Ire Rayos X, S.A.
·
,
Spain
Class I
CE/MDR
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
IB Lab SQUIRREL
IB Lab GmbH
·
,
Austria
Class IIa
CE/MDR
syngo Dynamics
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
RemotEye Viewer / RemotEye Lite
Neologica S.R.L.
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
MERLIN Diagnostic Workcenter
Phönix-PACS GmbH
·
,
Germany
Class I
CE/MDD
MERLIN Diagnostic Workcenter
Phönix-PACS GmbH
·
,
Germany
Class I
CE/MDD
Brainlab Elements Image Fusion, 4.5
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Lunit INSIGHT DBT
Lunit Inc.
·
,
South Korea
Class IIa
FDA 510(k)
K231470
Active
Cleared 6 Nov 2023
CE/MDR
+1
authorizations
Ultima Print Server
MPTronic
·
,
France
Class I
CE/MDR
syngo.MR Applications
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
Xeleris 4 DR Processing & Review Workstation
GE Medical Systems Israel, Functional Imaging
·
,
Israel
Class IIa
CE/MDD
GUDID
on market
Brainlab Elements Fibertracking, 2.0
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
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