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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
MyLab 8 eXP
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDD
Diagnostic Ultrasound System
Shenzhen Krinwave Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
FI25/1008014
Active
Valid to Jun 2030
Affiniti 70 Diagnostic Ultrasound System
Philips Ultrasound LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Affiniti CVx Diagnostic Ultrasound System
Philips Ultrasound LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
P15
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
GUDID
on market
P11N
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
P60
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
MyLabX8 eXP
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDD
CE/MDR
+1
authorizations
MyLab 9 eXP
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDD
GUDID
on market
MyLabA60
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDR
Linear array ultrasound probe
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIa
CE/MDR
S70S
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Medisono
Medisono LCC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
S85 Exp
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
P70S
Sonoscape Medical Corp.
·
,
China
Class IIa
CE/MDR
X-Cube 70
Alpinion Medical Systems Co., Ltd.
·
,
South Korea
Class IIa
FDA 510(k)
×2
K211299
Active
Cleared 9 Aug 2021
CE/MDR
+1
authorizations
Medisono
Medisono LCC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
Medisono
Medisono LCC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
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