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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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Ultrasound scanners - medical device software
Ultrasound scanners - medical device software
Z11040192
23 devices
Devices
Vscan Air
GE Vingmed Ultrasound AS
·
,
NO
Class IIa
CE/MDR
GUDID
on market
Venue Sprint
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Vscan Air
GE Vingmed Ultrasound AS
·
,
NO
Class IIa
CE/MDR
GUDID
on market
EchoPAC Plug-in
Ge Vingmed Ultrasound
·
,
NO
Class IIa
CE/MDR
GUDID
on market
Ventripoint Medical System Plus (VMS+)
Ventripoint Diagnostics Ltd.
·
,
CA
Class IIa
CE/MDR
28620149878-02
Active
Valid to Dec 2027
FDA 510(k)
K173810
Active
Cleared 14 May 2018
+2
authorizations
Ventripoint Medical System Plus
Ventripoint Diagnostics Ltd.
·
,
CA
Class IIa
FDA 510(k)
K241222
Active
Cleared 26 Feb 2025
CE/MDR
4D View 18
GE Healthcare Austria GmbH & Co OG
·
,
AT
Class IIa
FDA 510(k)
K253639
Active
Cleared 8 Jan 2026
FDA 510(k)
K131118
Active
Cleared 16 May 2013
+2
authorizations
Invenia ABUS
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
·
,
US
Class IIa
CE/MDR
Vscan Air
GE Vingmed Ultrasound AS
·
,
NO
Class IIa
CE/MDR
GUDID
on market
Vscan Air
Ge Vingmed Ultrasound
·
,
NO
Class IIa
CE/MDR
EchoPAC Software Only
Ge Vingmed Ultrasound
·
,
NO
Class IIa
CE/MDR
GUDID
on market
EchoPAC Plug-in
GE Vingmed Ultrasound AS
·
,
NO
Class IIa
FDA 510(k)
K123894
Active
Cleared 29 Jan 2013
FDA 510(k)
K150085
Active
Cleared 2 Mar 2015
+3
authorizations
Venue Sprint
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
·
,
US
Class IIa
FDA 510(k)
K240206
Active
Cleared 10 Jun 2024
CE/MDR
+1
authorizations
EchoPAC Software Only
GE Vingmed Ultrasound AS
·
,
NO
Class IIa
CE/MDR
GUDID
on market
Vscan Air
Ge Vingmed Ultrasound
·
,
NO
Class IIa
CE/MDR
GUDID
on market
Promap Lite
Koelis
·
,
FR
Class I
CE/MDD
GUDID
on market
Aco Smartcare
Aco Healthcare Co., Ltd.
·
,
TW
Class IIa
CE/MDR
Vscan Air
GE Vingmed Ultrasound AS
·
,
NO
Class IIa
CE/MDR
GUDID
on market
Aco Smartcare
Aco Healthcare Co., Ltd.
·
,
TW
Class IIa
CE/MDR
Voluson SWIFT to BT23 UPG
Ge Ultrasound Korea, Ltd.
·
,
KR
Class IIa
CE/MDR
GUDID
on market
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