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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Magnetic resonance imaging (MRI) instruments
Magnetic resonance imaging (MRI) instruments
Z1105
732 devices
Subcategories
2
Z110501
Magnetic resonance (mr) systems
506
devices
›
Z110590
Various magnetic resonance imaging (MRI) instruments
226
devices
›
Devices
Neuro Insight V1.0
Olea Medical S.A.S.
·
,
France
Class IIa
FDA 510(k)
K243681
Active
Cleared 23 Jul 2025
CE/MDR
MRI EVOlution 25
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDR
Olea S.I.A. Neurovascular V1.0
Olea Medical S.A.S.
·
,
France
Class IIa
FDA 510(k)
K223532
Active
Cleared 6 Jun 2023
CE/MDR
Functional MR V1.0
Open recall
Olea Medical S.A.S.
·
,
France
Class IIa
FDA 510(k)
K221426
Active
Cleared 6 Jul 2022
CE/MDR
MR DWI/FLAIR Measurement V1.0
Olea Medical S.A.S.
·
,
France
Class IIa
FDA 510(k)
K230552
Active
Cleared 26 Apr 2023
CE/MDR
CT Perfusion V1.0
Olea Medical S.A.S.
·
,
France
Class IIa
FDA 510(k)
K223091
Active
Cleared 9 Jun 2023
CE/MDR
AI DWI Mismatch V1.0
Olea Medical S.A.S.
·
,
France
Class IIa
CE/MDR
SyMRI 15
SyntheticMR AB
·
,
Sweden
Class IIa
CE/MDR
28620110677-01
Expiring
Valid to Sep 2027
GUDID
on market
Neurovascular Insight V1.0
Olea Medical S.A.S.
·
,
France
Class IIa
FDA 510(k)
K243680
Active
Cleared 25 Aug 2025
CE/MDR
Options IB Prodiva 1.5T R5
Philips Healthcare (Suzhou) Co., Ltd.
·
,
China
Class IIb
CE/MDR
Olea Sphere V3.0
Olea Medical S.A.S.
·
,
France
Class IIa
FDA 510(k)
×3
K120196
Active
Cleared 19 Apr 2012
CE/MDR
Transaflow Multi-APS 24h safety MR/CT mehrfach Füllsystem zur Kontrastmittelver…
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
Transaflow Multi-APS 55 safety MR/CT mehrfach Füllsystem zur Kontrastmittelvera…
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
Transaflow Multi-APS 11 safety MR/CT mehrfach Füllsystem zur Kontrastmittelvera…
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
RöKo-Filling-Line 2M
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
RöKo-Filling-Line 1
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
Vision X KS-311 safety Doppelkopffüllsystem
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
Transaflow Multi-APS 23 safety MR/CT mehrfach Füllsystem zur Kontrastmittelvera…
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
Transaflow Multi-APS 20 safety MR/CT mehrfach Füllsystem zur Kontrastmittelvera…
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
RöKo-Filling-Line 2
CARDEA GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
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