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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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Instruments for extraoral dental radiology
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Equipment for extraoral dental radiology
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Equipment for extraoral dental radiology, digital
Equipment for extraoral dental radiology, digital
Z1103030102
88 devices
Devices
PAPAYA 3D Premium Plus
Genoray Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K200469
Active
Cleared 16 Sep 2020
CE/MDD
+1
authorizations
seethroughFLEX XRE-200
W&H Sterilization Srl
·
,
IT
Class IIb
CE/MDR
PAPAYA 3D Plus (VOLUX 55)
Genoray Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K220392
Active
Cleared 19 May 2022
FDA 510(k)
K150354
Active
Cleared 10 Dec 2015
+2
authorizations
seethroughMAX XRE-100
W&H Sterilization Srl
·
,
IT
Class IIb
CE/MDR
X-MIND optima 3D
de Götzen S.r.l.
·
,
IT
Class IIb
CE/MDR
xgenus Aries 3D
de Götzen S.r.l.
·
,
IT
Class IIb
CE/MDR
bright CT
Dentium Co., Ltd. (ICT Branch)
·
,
KR
Class IIb
CE/MDR
GUDID
on market
NewTom VG-One
CEFLA s.c.
·
,
IT
Class IIb
CE/MDR
bright CT
Dentium Co., Ltd. (ICT Branch)
·
,
KR
Class IIb
CE/MDR
GUDID
on market
ProXIma X6
CEFLA s.c.
·
,
IT
Class IIb
CE/MDR
X-View 1000
CEFLA s.c.
·
,
IT
Class IIb
CE/MDR
Dental X-ray Tomographic System
LargeV Instrument Corp., Ltd.
·
,
CN
Class IIb
CE/MDR
X-MIND optima 3D
de Götzen S.r.l.
·
,
IT
Class IIb
CE/MDR
xgenus Aries 3D
de Götzen S.r.l.
·
,
IT
Class IIb
CE/MDR
Papaya(Gdp-1)
Genoray Co., Ltd.
·
,
KR
Class IIb
CE/MDD
GUDID
on market
bright CT
Dentium Co., Ltd. (ICT Branch)
·
,
KR
Class IIb
CE/MDR
GUDID
on market
PAPAYA Plus(GDP-1C, VOLUX 29)
Genoray Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K220423
Active
Cleared 19 May 2022
CE/MDD
+1
authorizations
X-MIND optima 3D
de Götzen S.r.l.
·
,
IT
Class IIb
CE/MDR
NewTom VG-One
CEFLA s.c.
·
,
IT
Class IIb
CE/MDR
hyperion X9 pro
CEFLA s.c.
·
,
IT
Class IIb
CE/MDR
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