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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
Devices
Color Doppler Ultrasound System
Wuhan Zoncare Bio-medical Electronics Co., Ltd
·
,
CN
Class IIa
CE/MDR
HS50
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
Logiq P8, Logiq P9, Logiq P10
Ge Ultrasound Korea, Ltd.
·
,
KR
Class IIa
CE/MDR
GUDID
on market
HS70A
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
Voluson S10
Ge Ultrasound Korea, Ltd.
·
,
KR
Class IIa
CE/MDR
GUDID
on market
RS85
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
HS40
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
Hera W9
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
Hera Z30
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
LOGIQ Totus, LOGIQ Totus HDU
Ge Ultrasound Korea, Ltd.
·
,
KR
Class IIa
CE/MDR
Hisense
Qingdao Hisense Medical Co., Ltd.
·
,
CN
Class IIa
CE/MDR
HS50
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
HM70 Evo
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
Venue Go
Open recall
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
·
,
US
Class IIa
FDA 510(k)
K240053
Active
Cleared 10 Jun 2024
CE/MDR
RS85
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
HS30
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
HS50
Samsung Medison Co., Ltd.
·
,
KR
Class IIa
CE/MDR
Delica
Shenzhen Delica Medical Equipment Co., Ltd.
·
,
CN
Class IIa
CE/MDR
GUDID
on market
LOGIQ Totus, LOGIQ Totus HDU
Ge Ultrasound Korea, Ltd.
·
,
KR
Class IIa
CE/MDR
Hisense
Qingdao Hisense Medical Co., Ltd.
·
,
CN
Class IIa
CE/MDR
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