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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Various bioimaging and radiotherapy instruments
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Various bioimaging and radiotherapy instruments - software accessories
Various bioimaging and radiotherapy instruments - software accessories
Z119082
42 devices
Quantib Prostate
Quantib BV
·
,
Netherlands
Class IIb
CE/MDR
GUDID
on market
Quantib ND 2.1
Quantib BV
·
,
Netherlands
Class IIa
CE/MDR
SCAR-13.2.2.1
Active
Valid to Aug 2030
GUDID
on market
X-Tray 3.22.1
Krucom AB
·
,
Sweden
Class I
CE/MDR
Quantib AI Node 2.8
Quantib BV
·
,
Netherlands
Class IIb
CE/MDR
GUDID
on market
Fluosoft Ls
Fluoptics SAS
·
,
France
Class IIa
CE/MDR
Brain Age
Deephealth
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Fluosoft Lm
Fluoptics SAS
·
,
France
Class IIa
CE/MDR
Fluosoft Lx
Fluoptics SAS
·
,
France
Class IIa
CE/MDR
Quantib Brain 1.5
Quantib BV
·
,
Netherlands
Class IIa
CE/MDR
SCAR-13.2.2.1
Active
Valid to Aug 2030
GUDID
on market
FLUOSOFT LX Red
Fluoptics SAS
·
,
France
Class IIa
CE/MDR
X-Tray 3.20.0
Krucom AB
·
,
Sweden
Class I
CE/MDR
Simq OSA
Simq GmbH
·
,
Germany
Class IIb
CE/MDR
Brain Health
Deephealth
·
,
United States
Class IIa
CE/MDR
MedDream
UAB MedDream
·
,
Lithuania
Class IIb
CE/MDR
GUDID
on market
nCommand Lite
Ionic Health Technologies S/A
·
,
Brazil
Class IIb
CE/MDR
GUDID
on market
California
Optos plc
·
,
United Kingdom
Class IIa
FDA 510(k)
K142897
Active
Cleared 16 Jan 2015
CE/MDR
+1
authorizations
Silverstone
Optos plc
·
,
United Kingdom
Class IIa
FDA 510(k)
K190732
Active
Cleared 31 Jul 2019
CE/MDR
+1
authorizations
Daytona
Optos plc
·
,
United Kingdom
Class IIa
FDA 510(k)
K111628
Active
Cleared 19 Aug 2011
CE/MDR
+1
authorizations
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