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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 - software accessories
Ultrasound scanners - software accessories
Z11040182
16 devices
Devices
Caption Guidance
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
UltraSight Guidance
Ultrasight
·
,
IL
Class I
FDA 510(k)
K251416
Active
Cleared 17 Dec 2025
CE/MDR
uSINE
HiCura Medical Pte Ltd
·
,
SG
Class IIa
CE/MDR
uSINE
HiCura Medical Pte Ltd
·
,
SG
Class IIa
CE/MDR
Lung Guidance
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
·
,
US
Class IIa
CE/MDR
EchoRapp
Medirapp AG
·
,
CH
Class I
CE/MDR
Caption AI
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Caption Guidance
Caption Health, Inc.
·
,
US
Class IIa
FDA 510(k)
K201992
Active
Cleared 18 Sep 2020
FDA 510(k)
K200755
Active
Cleared 16 Apr 2020
+2
authorizations
UroNav
Philips Ds North America LLC
·
,
US
Class IIa
FDA 510(k)
K250800
Active
Cleared 5 Jun 2025
CE/MDR
+1
authorizations
OvAi Focus
SynDiag s.r.l.
·
,
IT
Class I
CE/MDR
Clarius App - iOS
Clarius Mobile Health Corp.
·
,
CA
Class IIa
CE/MDR
GUDID
on market
Caption Interpretation
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
·
,
US
Class IIa
CE/MDR
Clarius App - Android
Clarius Mobile Health Corp.
·
,
CA
Class IIa
CE/MDR
GUDID
on market
OvAi Focus
SynDiag s.r.l.
·
,
IT
Class I
CE/MDR
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