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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
Xeleris V Processing & Review System
GE Hualun Medical Systems Co., Ltd
·
,
China
Class IIa
FDA 510(k)
K221680
Active
Cleared 1 Mar 2023
CE/MDR
QP-Prostate®
Quibim S.L.
·
,
Spain
Class IIb
CE/MDR
Orthodontic Treatment Planning Software
Shanghai EA Medical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
qCT
Qure.ai Technologies Private Limited
·
,
India
Class IIb
CE/MDR
Syngo Carbon Clinicals
Siemens Healthcare GmbH
·
,
Germany
Class IIb
FDA 510(k)
K232856
Active
Cleared 1 Dec 2023
CE/MDR
+1
authorizations
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
AI-Rad Companion Organs RT
Siemens Healthcare GmbH
·
,
Germany
Class IIb
FDA 510(k)
×2
K242745
Active
Cleared 27 Mar 2025
CE/MDR
+1
authorizations
MyLabDesk
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDR
Contrast&Care+
Medex
·
,
France
Class I
CE/MDD
Brainlab Elements Fibertracking, 3.0
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
RAPID Software
iSchemaView, Inc.
·
,
United States
Class IIa
FDA 510(k)
×5
K121447
Active
Cleared 4 Oct 2013
CE/MDD
Brainlab Elements BOLD MRI Mapping, 1.0
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
SHLView Version 4.07
SHL Solutions for Healthcare and Life-Sciences GmbH
·
,
Austria
Class IIb
CE/MDR
GXD5 Diagnostics
Enovacom
·
,
France
Class IIa
CE/MDD
QP-Prostate®
Quibim S.L.
·
,
Spain
Class IIb
CE/MDR
AI-Rad Companion Chest CT
Siemens Healthineers AG
·
,
Germany
Class IIb
CE/MDR
RemotEye Viewer / RemotEye Lite
Neologica S.R.L.
·
,
Italy
Class IIa
CE/MDR
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
AI-Rad Companion Prostate MR
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Brainlab Elements Image Fusion, 4.0
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
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