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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
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Internal ultrasound scanners
Internal ultrasound scanners
Z11040101
1,010 devices
Diagnostic Ultrasound System
Edan Instruments, Inc.
·
,
China
Class IIa
FDA 510(k)
K180408
Active
Cleared 13 Apr 2018
CE/MDR
+1
authorizations
LOGIQ Fortis
Ge Ultrasound Korea, Ltd.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
HS30
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Hera W9
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Voluson SWIFT
Ge Ultrasound Korea, Ltd.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
HS70A
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Versana Premier, Versana Premier Lotus
GE Medical Systems CO. Ltd
·
,
China
Class IIa
CE/MDR
GUDID
on market
Diagnostic Ultrasound System
Edan Instruments, Inc.
·
,
China
Class IIa
CE/MDR
HM70 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HM70 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
cV6 ONE
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HS40
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HS60
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HM70 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Versana Balance
GE Medical Systems CO. Ltd
·
,
China
Class IIa
CE/MDR
GUDID
on market
HS60
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HM70 Evo
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
Hera W10
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HS40
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
HS30
Samsung Medison Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
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