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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Computed tomographs (CT)
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Computed tomographs (CT) - other
Computed tomographs (CT) - other
Z11030699
33 devices
CT Gantry Cover G25
Pearl Technology AG
·
,
Switzerland
Class I
CE/MDR
GUDID
on market
NewTom 7G
CEFLA s.c.
·
,
Italy
Class IIb
FDA 510(k)
K220664
Active
Cleared 6 May 2022
CE/MDR
+1
authorizations
CT Gantry Cover C307
Pearl Technology AG
·
,
Switzerland
Class I
CE/MDR
GUDID
on market
CT Gantry Cover P60
Pearl Technology AG
·
,
Switzerland
Class I
CE/MDR
GUDID
on market
HiRise
CurveBeam LLC
·
,
United States
Class IIb
CE/MDR
28620146078-02
Active
Valid to Jun 2027
FDA 510(k)
K203187
Active
Cleared 18 Nov 2020
+1
authorizations
ARTiCAT
RAR s.r.l.
·
,
Italy
Class IIb
CE/MDR
Phion 2.0
L&C AI Co., Ltd
·
,
South Korea
Class IIb
CE/MDD
Ct:vq
4Dmedical Limited
·
,
Australia
Class IIa
FDA 510(k)
K251484
Active
Cleared 28 Aug 2025
CE/MDR
+1
authorizations
NewTom 5G XL
CEFLA s.c.
·
,
Italy
Class IIb
FDA 510(k)
K183448
Active
Cleared 8 Mar 2019
CE/MDR
+1
authorizations
Dental Cone-beam Computed Tomography
Hefei Meyer Optoelectronic Technology Inc.
·
,
China
Class IIb
CE/MDR
CT Gantry Cover C202
Pearl Technology AG
·
,
Switzerland
Class I
CE/MDR
GUDID
on market
CT Gantry Cover C308
Pearl Technology AG
·
,
Switzerland
Class I
CE/MDR
GUDID
on market
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