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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 - software accessories
Radiology instruments - software accessories
Z11030582
48 devices
Devices
Methinks Stroke Suite
Methinks Software SL
·
,
ES
Class IIb
CE/MDR
mint Lesion
Mint Medical GmbH
·
,
DE
Class IIb
CE/MDR
GUDID
on market
cvi42
Circle Cardiovascular Imaging Inc
·
,
CA
Class IIa
CE/MDD
FDA 510(k)
K213998
Active
Cleared 28 Jul 2022
+3
authorizations
Annalise Enterprise
Harrison-Ai Medical Pty Ltd
·
,
AU
Class IIb
CE/MDR
GUDID
on market
Tempus Pixel
Arterys Inc.
·
,
US
Class IIa
FDA 510(k)
K252539
Active
Cleared 3 Sep 2025
CE/MDR
QyScore
Qynapse
·
,
FR
Class IIa
CE/MDR
CE/MDD
+1
authorizations
SubtleHD
Subtle Medical, Inc.
·
,
US
Class IIa
FDA 510(k)
K243250
Active
Cleared 12 Feb 2025
CE/MDR
Annalise Enterprise
Harrison-Ai Medical Pty Ltd
·
,
AU
Class IIb
CE/MDR
GUDID
on market
mint Lesion
Open recall
Mint Medical GmbH
·
,
DE
Class IIb
FDA 510(k)
K142647
Active
Cleared 13 Apr 2015
CE/MDR
Annalise Web Viewer
Harrison-Ai Medical Pty Ltd
·
,
AU
Class I
CE/MDR
Annalise Enterprise
Harrison-Ai Medical Pty Ltd
·
,
AU
Class IIb
FDA 510(k)
K253818
Active
Cleared 3 Mar 2026
FDA 510(k)
K250831
Active
Cleared 23 Apr 2025
+2
authorizations
RBfracture
Radiobotics ApS
·
,
DK
Class IIa
CE/MDR
Nexo
ACIST Medical Systems, Inc.
·
,
US
Class I
CE/MDR
contextflow SEARCH Lung CT
contextflow GmbH
·
,
AT
Class IIa
CE/MDR
contextflow ADVANCE Chest CT
contextflow GmbH
·
,
AT
Class IIa
CE/MDR
SubtlePET (Software as a Service for post-processing of Positron Emission Tomog…
Subtle Medical, Inc.
·
,
US
Class IIa
CE/MDR
28620157147
Active
Valid to Jul 2028
GUDID
on market
contextflow ADVANCE Chest CT
contextflow GmbH
·
,
AT
Class IIa
CE/MDR
mint Lesion
Mint Medical GmbH
·
,
DE
Class IIb
CE/MDR
GUDID
on market
contextflow ADVANCE Chest CT
contextflow GmbH
·
,
AT
Class IIa
CE/MDR
contextflow ADVANCE Chest CT
contextflow GmbH
·
,
AT
Class IIa
CE/MDR
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