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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
AW Server (version: 3.2)
GE Medical Systems SCS
·
,
France
Class IIa
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
AI Contouring
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
ZEEROmed View
O3 Enterprise srl
·
,
Italy
Class IIa
FDA 510(k)
K200546
Active
Cleared 5 May 2020
CE/MDR
3D-Cam Pilot
Digitec S.r.l.
·
,
Italy
Class I
CE/MDR
Image Management
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
GUDID
on market
Suitestensa
EBIT s.r.l.
·
,
Italy
Class IIa
CE/MDR
Augmento
Deeptek Medical Imaging Private Limited
·
,
India
Class I
FDA 510(k)
K222781
Active
Cleared 11 Apr 2023
CE/MDR
+1
authorizations
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
O3IMS.View
O3 Enterprise srl
·
,
Italy
Class IIa
CE/MDR
StrokeViewer Image Viewer
ResolutionMD Inc.
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Lunit INSIGHT CXR
Lunit Inc.
·
,
South Korea
Class IIa
FDA 510(k)
K211733
Active
Cleared 10 Nov 2021
CE/MDR
syngo Carbon Space
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Reveal Family
Ceevra, Inc.
·
,
United States
Class IIa
FDA 510(k)
×3
K243933
Active
Cleared 4 Mar 2025
CE/MDR
+1
authorizations
Ire Store Channel
Ire Rayos X, S.A.
·
,
Spain
Class I
CE/MDR
Ims Giotto
Ims Giotto S.P.A.
·
,
Italy
Class I
CE/MDR
Briefcase-Triage
Aidoc Medical Ltd
·
,
Israel
Class IIa
FDA 510(k)
×28
K261317
Active
Cleared 14 May 2026
CE/MDR
inHEART Models Shaper
Inheart
·
,
France
Class IIa
CE/MDR
BoneXpert
Visiana ApS
·
,
Denmark
Class I
CE/MDD
E-MRI EVO Viewer
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDR
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