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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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Various instruments for radiodiagnostics and interventional procedures
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Various radiodiagnostic and interventional instruments - software accessories
Various radiodiagnostic and interventional instruments - software accessories
Z11039082
61 devices
Ares
Ares Medikal Sanayi Ticaret Ltd. Şti.
·
,
Türkiye
Class IIa
CE/MDD
LungCT
Gleamer Sas
·
,
France
Class IIa
CE/MDR
CAD4TBBox
Delft Imaging Systems B.V.
·
,
Netherlands
Class IIb
CE/MDR
DoseWatch
GE Medical Systems SCS
·
,
France
Class I
CE/MDR
CAAS Workstation
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
Ares
Ares Medikal Sanayi Ticaret Ltd. Şti.
·
,
Türkiye
Class IIa
CE/MDD
Ares
Ares Medikal Sanayi Ticaret Ltd. Şti.
·
,
Türkiye
Class IIa
CE/MDD
CAAS Workstation
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
CAAS IntraVascular
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
CAAS Workstation
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
CAAS A-Valve
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
CE/MDD
3mensio Workstation
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
BoneCT
Gleamer Sas
·
,
France
Class IIa
CE/MDR
BoneView
Gleamer Sas
·
,
France
Class IIa
FDA 510(k)
×2
K212365
Active
Cleared 1 Mar 2022
CE/MDR
CAAS Qardia
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
FDA 510(k)
K212376
Active
Cleared 16 May 2022
CE/MDD
Ares
Ares Medikal Sanayi Ticaret Ltd. Şti.
·
,
Türkiye
Class IIa
CE/MDD
Ares
Ares Medikal Sanayi Ticaret Ltd. Şti.
·
,
Türkiye
Class IIa
CE/MDD
3mensio Workstation
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
CAAS IntraVascular
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
FDA 510(k)
K123970
Active
Cleared 6 Feb 2013
CE/MDD
+1
authorizations
3mensio Workstation
Open recall
Pie Medical Imaging B.V.
·
,
Netherlands
Class IIa
FDA 510(k)
×3
K250330
Active
Cleared 3 Nov 2025
CE/MDD
+1
authorizations
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