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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
Devices
Quantib ND 1.6
Quantib BV
·
,
NL
Class IIa
CE/MDR
SCAR-13.2.2.1
Active
Valid to Aug 2030
FDA 510(k)
K213737
Active
Cleared 14 Jan 2022
+2
authorizations
Quantib Prostate 3.3
Quantib BV
·
,
NL
Class IIb
CE/MDR
GUDID
on market
OptosAdvance
Optos plc
·
,
GB
Class IIa
FDA 510(k)
K113696
Active
Cleared 25 May 2012
CE/MDR
+1
authorizations
X-Tray 3.24.0
Krucom AB
·
,
SE
Class I
CE/MDR
Quantib Prostate 3.1
Quantib BV
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Ligence Heart
UAB Ligence
·
,
LT
Class IIa
FDA 510(k)
K252105
Active
Cleared 26 Sep 2025
FDA 510(k)
K253535
Active
Cleared 27 Feb 2026
+1
authorizations
Avatar Medical Vision
Avatar Medical
·
,
FR
Class IIa
FDA 510(k)
K253950
Active
Cleared 30 Mar 2026
CE/MDR
+1
authorizations
RADU v.16.0
L-Force Oy
·
,
FI
Class I
CE/MDR
X-Tray 3.25.0
Krucom AB
·
,
SE
Class I
CE/MDR
Quantib AI Node 2.7
Quantib BV
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Quantib AI Node
Quantib BV
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Quantib AI Node 2.6
Quantib BV
·
,
NL
Class IIb
FDA 510(k)
K200899
Active
Cleared 15 Jun 2020
CE/MDR
+1
authorizations
Breast-SlimView®
Hera-MI
·
,
FR
Class IIa
CE/MDR
CE/MDD
Radu RIS v.20.0.3
L-Force Oy
·
,
FI
Class I
CE/MDR
ArtFun+
Imageens
·
,
FR
Class IIa
CE/MDR
X-Tray 3.22.0
Krucom AB
·
,
SE
Class I
CE/MDR
X-Tray 3.23.0
Krucom AB
·
,
SE
Class I
CE/MDR
RIT Family of Products
Radiological Imaging Technology, Inc.
·
,
US
Class I
CE/MDR
GUDID
on market
Radu RIS v.20.1
L-Force Oy
·
,
FI
Class I
CE/MDR
Quantib Prostate 3.2
Quantib BV
·
,
NL
Class IIb
FDA 510(k)
K202501
Active
Cleared 11 Oct 2020
FDA 510(k)
K221106
Active
Cleared 13 May 2022
+3
authorizations
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