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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
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Magnetic resonance (mr) systems
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Magnetic resonance (mr) systems - software accessories
Magnetic resonance (mr) systems - software accessories
Z11050182
15 devices
Devices
DynaCAD
Philips Ds North America LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
breastscape V1.0
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K211431
Active
Cleared 2 Aug 2021
CE/MDR
SyMRI 12
SyntheticMR AB
·
,
SE
Class IIa
CE/MDR
28620110677-01
Active
Valid to Sep 2027
FDA 510(k)
K181093
Active
Cleared 12 Jun 2018
+5
authorizations
Neuro Insight V1.0
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K243681
Active
Cleared 23 Jul 2025
CE/MDR
MRI EVOlution 25
Esaote S.p.A.
·
,
IT
Class IIa
CE/MDR
Olea S.I.A. Neurovascular V1.0
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K223532
Active
Cleared 6 Jun 2023
CE/MDR
Functional MR V1.0
Open recall
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K221426
Active
Cleared 6 Jul 2022
CE/MDR
MR DWI/FLAIR Measurement V1.0
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K230552
Active
Cleared 26 Apr 2023
CE/MDR
CT Perfusion V1.0
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K223091
Active
Cleared 9 Jun 2023
CE/MDR
AI DWI Mismatch V1.0
Olea Medical S.A.S.
·
,
FR
Class IIa
CE/MDR
SyMRI 15
SyntheticMR AB
·
,
SE
Class IIa
CE/MDR
28620110677-01
Active
Valid to Sep 2027
GUDID
on market
Neurovascular Insight V1.0
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K243680
Active
Cleared 25 Aug 2025
CE/MDR
Options IB Prodiva 1.5T R5
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Olea Sphere V3.0
Olea Medical S.A.S.
·
,
FR
Class IIa
FDA 510(k)
K120196
Active
Cleared 19 Apr 2012
FDA 510(k)
K152602
Active
Cleared 3 Mar 2016
+2
authorizations
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