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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Various instruments for radiodiagnostics and interventional procedures
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Various radiodiagnostic and interventional instruments - medical device software
Various radiodiagnostic and interventional instruments - medical device software
Z11039092
32 devices
Devices
Cina
Avicenna.ai
·
,
FR
Class IIb
CE/MDR
Floy Vision
Floy GmbH
·
,
DE
Class IIb
CE/MDR
Quality Care Suite 2.0
Ge Medical Systems, Inc.
·
,
US
Class I
CE/MDR
GUDID
on market
DOSE-Patient radiation dose monitoring software
Qaelum NV
·
,
BE
Class IIb
CE/MDR
Cina-Aspects
Avicenna.ai
·
,
FR
Class I
CE/MDD
FEops HEARTguide
FEops NV
·
,
BE
Class IIa
FDA 510(k)
K223855
Active
Cleared 6 Jun 2023
CE/MDR
Cina-Chest
Avicenna.ai
·
,
FR
Class I
CE/MDD
Signal MR Vertebra
Floy GmbH
·
,
DE
Class I
CE/MDR
Signal MR Shoulder
Floy GmbH
·
,
DE
Class I
CE/MDR
CINA-VCF Quantix
Avicenna.ai
·
,
FR
Class IIb
FDA 510(k)
K240612
Active
Cleared 31 May 2024
CE/MDR
Signal CT Abdomen
Floy GmbH
·
,
DE
Class I
CE/MDR
Signal MR Spine
Floy GmbH
·
,
DE
Class I
CE/MDR
FEops HEARTguide
FEops NV
·
,
BE
Class IIa
CE/MDR
Signal MR Head
Floy GmbH
·
,
DE
Class I
CE/MDR
LumbarMR
Gleamer Sas
·
,
FR
Class IIa
CE/MDR
CINA-iPE
Avicenna.ai
·
,
FR
Class IIb
FDA 510(k)
K233968
Active
Cleared 13 Mar 2024
CE/MDR
Cina-Aspects
Avicenna.ai
·
,
FR
Class IIb
FDA 510(k)
K233342
Active
Cleared 15 Mar 2024
FDA 510(k)
K200855
Active
Cleared 24 Jun 2020
+2
authorizations
Domako
medigration GmbH
·
,
DE
Class I
CE/MDR
CINA-CSpine
Avicenna.ai
·
,
FR
Class IIb
FDA 510(k)
K240942
Active
Cleared 12 Sep 2024
CE/MDR
Signal BMD
Floy GmbH
·
,
DE
Class I
CE/MDR
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