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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Echography instruments
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Ultrasound scanners
/
Internal ultrasound scanners
Internal ultrasound scanners
Z11040101
1,010 devices
HS40
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Hisense
Qingdao Hisense Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
V8
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
HM70 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
R30
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
HS50
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
V5
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Hisense
Qingdao Hisense Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Hisense
Qingdao Hisense Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Endoscopic Ultrasound System
InnerMedical Co., Ltd.
·
,
China
Class IIa
CE/MDR
Hera W10
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Voluson S10 Expert
Ge Ultrasound Korea, Ltd.
·
,
South Korea
Class IIa
FDA 510(k)
×2
K180374
Active
Cleared 13 Mar 2018
CE/MDR
+1
authorizations
RS80 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Ems-9D Pro
Shenzhen Delica Medical Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDD
GUDID
on market
Hisense
Qingdao Hisense Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
HS70A
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HM70 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Hisense
Qingdao Hisense Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
HM70 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Diagnostic Ultrasound System
Edan Instruments, Inc.
·
,
China
Class IIa
CE/MDR
GUDID
on market
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