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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Digital bioimaging management instruments
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Various digital bioimaging management instruments
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Various digital bioimaging management instruments - medical device software
Various digital bioimaging management instruments - medical device software
Z11069092
204 devices
Devices
Cervical Cell Pathology Image Analysis Software
SenseCare Smart Health Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
Brainlab Elements Image Fusion, 5.0
Brainlab SE
·
,
DE
Class IIb
FDA 510(k)
K243633
Active
Cleared 13 Jun 2025
CE/MDR
+1
authorizations
qER-NCCT
Qure.ai Technologies Private Limited
·
,
IN
Class IIb
CE/MDR
Veye Lung Nodules
Aidence B.V.
·
,
NL
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
PMA.core
Pathomation BV
·
,
BE
IVD General
CE/IVDD
DS Core Diagnosis
Zetta25 AG
·
,
CH
Class IIa
CE/MDR
Spine Planning 3.0
Brainlab SE
·
,
DE
Class IIb
CE/MDR
DS Core Diagnosis
Zetta25 AG
·
,
CH
Class IIa
CE/MDR
Veye Lung Nodules
Aidence B.V.
·
,
NL
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
DI Scan
Zetta25 AG
·
,
CH
Class I
CE/MDR
GUDID
on market
Brainlab Elements Image Fusion Angio, 1.0
Brainlab SE
·
,
DE
Class IIb
FDA 510(k)
K212420
Active
Cleared 16 Dec 2021
FDA 510(k)
K190042
Active
Cleared 25 Apr 2019
+2
authorizations
AI-Rad Companion Chest X-ray
Siemens Healthineers AG
·
,
DE
Class IIb
CE/MDR
Veye Lung Nodules
Aidence B.V.
·
,
NL
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
Blackford Accept Reject Tool
Blackford Analysis Ltd
·
,
GB
Class I
CE/MDR
Brainlab Elements - Trajectory Planning, 2.5
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
Veye Lung Nodules
Aidence B.V.
·
,
NL
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
Veye Lung Nodules
Aidence B.V.
·
,
NL
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
Brainlab Elements Contouring, 4.0
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
Ablation-fit
R.A.W. Srl
·
,
IT
Class IIa
FDA 510(k)
K222938
Active
Cleared 12 Sep 2023
CE/MDR
IB Lab LAMA
IB Lab GmbH
·
,
AT
Class IIa
FDA 510(k)
K223646
Active
Cleared 16 Jun 2023
CE/MDR
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