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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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Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
Z11040104
1,578 devices
Ultrasonic Diagnostic System
Shenzhen Wisonic Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDD
GUDID
on market
Diagnostic ultrasound system
Carbon (Shenzhen) Medical Device Co., Ltd.
·
,
China
Class IIa
CE/MDR
P30S
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Marvo 70i
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
Ultrasonic Diagnostic System
Shenzhen Wisonic Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDD
GUDID
on market
Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Fenix 95 Elite
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
Diagnostic Ultrasound System
Shenzhen Krinwave Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
×6
K180912
Active
Cleared 30 Jul 2018
CE/MDR
+1
authorizations
Medisono
Medisono LCC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIa
CE/MDR
P25
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Convex array ultrasound probe
Shenzhen Comen Medical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
MyLab 8 eHD
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDD
MyLabE850 AI
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDR
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
MU6 Elite
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIa
CE/MDR
Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIa
CE/MDR
Affiniti CVx Diagnostic Ultrasound System
Philips Ultrasound LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
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