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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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Various magnetic resonance imaging (MRI) instruments
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Various magnetic resonance imaging instruments - software accessories
Various magnetic resonance imaging instruments - software accessories
Z11059082
8 devices
Devices
AMRA Profiler 4
AMRA Medical AB
·
,
SE
Class IIb
FDA 510(k)
K211983
Active
Cleared 24 Nov 2021
FDA 510(k)
K173749
Active
Cleared 6 Dec 2018
+1
authorizations
Mrcp+
Perspectum, Ltd.
·
,
GB
Class I
FDA 510(k)
K183133
Active
Cleared 9 Jan 2019
CE/MDD
LiverMultiScan
Perspectum, Ltd.
·
,
GB
Class IIa
CE/MDR
SCAR-22.2.1.1
Active
Valid to May 2029
FDA 510(k)
K202170
Active
Cleared 2 Oct 2020
+1
authorizations
Hepatogram plus
Resoundant
·
,
US
Class IIa
CE/MDD
GUDID
on market
Hepatica
Perspectum, Ltd.
·
,
GB
Class IIb
FDA 510(k)
K203280
Active
Cleared 12 Jan 2021
CE/MDR
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