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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
syngo.via View&GO
Siemens Healthcare GmbH
·
,
Germany
Class IIb
FDA 510(k)
×2
K221501
Active
Cleared 14 Oct 2022
CE/MDR
BMVision Kidney
Better Medicine OÜ
·
,
Estonia
Class IIa
CE/MDR
Orthodontic Treatment Planning Software
Shanghai EA Medical Instruments Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
K223518
Active
Cleared 13 Jun 2023
CE/MDR
+1
authorizations
Lumi Calculation Functions
Augmedit B.V.
·
,
Netherlands
Class I
CE/MDR
Paros
Incepto Medical SAS
·
,
France
Class IIa
CE/MDR
QP-Liver®
Quibim S.L.
·
,
Spain
Class IIa
CE/MDR
MeriConnect
O3 Enterprise srl
·
,
Italy
Class IIa
CE/MDR
qXR
Qure.ai Technologies Private Limited
·
,
India
Class IIb
CE/MDR
Advanced Imaging Toolkit
iSchemaView, Inc.
·
,
United States
Class IIb
CE/MDR
syngo.MR Applications
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Lumina 3D
iSchemaView, Inc.
·
,
United States
Class IIb
CE/MDR
Centricity Cardio Workflow v7.0
GE Healthcare
·
,
United States
Class I
CE/MDR
Arva
Incepto Medical SAS
·
,
France
Class IIa
CE/MDR
DS Core Resto
Zetta25 AG
·
,
Switzerland
Class IIa
CE/MDR
GUDID
on market
Heartflow Analysis
HeartFlow, Inc.
·
,
United States
Class IIb
FDA 510(k)
×3
K203329
Active
Cleared 8 Jan 2021
CE/MDR
+1
authorizations
ResolutionMD
ResolutionMD Inc.
·
,
Canada
Class IIa
CE/MDR
GUDID
on market
Trace4BUS
DeepTrace Technologies S.R.L.
·
,
Italy
Class IIa
CE/MDR
Med X-Ray 7.1
Med.e.com
·
,
France
Class IIa
CE/MDR
FR25/00000027
Active
Valid to Jan 2030
AI-Rad Companion Chest X-ray
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
Heuron IPD
Heuron Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
CE/MDD
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