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63 device results listed.

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StrokeSENS

v2.x

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Circle Cardiovascular Imaging Inc
Manufacturer SRN: CA-MF-000011835
UDI-DI: 00882916001025
Basic UDI-DI: 882916SSX6N
Reference: v2.x
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: QDossier B.V.
Last updated: 31.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

TruPlan

v3.x

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Circle Cardiovascular Imaging Inc
Manufacturer SRN: CA-MF-000011835
UDI-DI: 00882916000523
Basic UDI-DI: 882916TRP68
Reference: TruPlan v2.1
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: QDossier B.V.
Last updated: 31.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

Deep Learning Image Reconstruction

ver 1.1, ver 1.2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278620453
Basic UDI-DI: 8406821BUG00032GR
Reference: 5928863
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

BrainScan CT

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: BRAINSCAN SPÓŁKA AKCYJNA
Manufacturer SRN: PL-MF-000022152
UDI-DI: 05903699822616
Basic UDI-DI: 59036998226BrainscanCTFC
Reference: n/a
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:08

Manufacturer products View details

i-Dixel

Class IMDR 2017/745On the market

Manufacturer: J. MORITA MFG. CORP.
Manufacturer SRN: JP-MF-000023000
UDI-DI: 04548213030804
Basic UDI-DI: 4548213000B0022DV
Reference: i-Dixel
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Veolity

2.x

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MeVis Medical Solutions AG
Manufacturer SRN: DE-MF-000005418
UDI-DI: 04260483290237
Basic UDI-DI: 0426048329VEO35
Reference: Veo-2100-CS
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:41

Manufacturer products View details

04260483290138

1.x

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MeVis Medical Solutions AG
Manufacturer SRN: DE-MF-000005418
UDI-DI: 04260483290138
Basic UDI-DI: 0426048329MVLSXH
Reference: MVLS-1.2-F / MVLS-1.2-V
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:41

Manufacturer products View details

syngo.CT Coronary Cockpit

syngo.CT PP_IIa_App_ERLN H 127

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151012453
Basic UDI-DI: 0405686900118UT
Reference: 11664855
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

TruPlan

Class IIaNot specifiedOn the marketActive deviceDirect markingMeasuring function

Manufacturer: Circle Cardiovascular Imaging Inc
Manufacturer SRN: CA-MF-000011835
UDI-DI: 00882916000530
Basic UDI-DI: 882916TRP68
Reference: v3.x
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: QDossier B.V.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Veolity

2.x

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MeVis Medical Solutions AG
Manufacturer SRN: DE-MF-000005418
UDI-DI: 04260483290213
Basic UDI-DI: 0426048329VEO35
Reference: Veo-2000-CS
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:40

Manufacturer products View details

syngo.CT Coronary Analysis

syngo.CT PP_IIa_App_ERLN H 127

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869267289
Basic UDI-DI: 0405686900118UT
Reference: 11546303
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:10

Manufacturer products View details

+B816VNC2P20

Virtual Nodule Clinic

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Optellum Ltd
Manufacturer SRN: GB-MF-000002862
UDI-DI: +B816VNC2P20
Basic UDI-DI: ++B816VNC2P0YT
Reference: Virtual Nodule Clinic
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details

+B816LD0

LungDetect

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Optellum Ltd
Manufacturer SRN: GB-MF-000002862
UDI-DI: +B816LD0
Basic UDI-DI: ++B816LDAB
Reference: LungDetect
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details

+B816HMS0

Hermes

Class IMDR 2017/745On the marketActive device

Manufacturer: Optellum Ltd
Manufacturer SRN: GB-MF-000002862
UDI-DI: +B816HMS0
Basic UDI-DI: ++B816HMSSG
Reference: Hermes
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details

+B816VNC3P00

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Optellum Ltd
Manufacturer SRN: GB-MF-000002862
UDI-DI: +B816VNC3P00
Basic UDI-DI: ++B816VNC2P0YT
Reference: Virtual Nodule Clinic
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 06.07.2026 23:28

Manufacturer products Authorised representative products Authorised representative actors View details

CustoMED Viewer

Class IMDR 2017/745On the market

Manufacturer: CustoMED Ltd
Manufacturer SRN: IL-MF-000050512
UDI-DI: 07290020565006
Basic UDI-DI: 7290020565VIEWER9D
Reference: 07290020565006
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

InferOperate® Software

InferOperate 3D, InferOperate Thorax 3D, InferOperate Liver 3D, InferOperate Urology 3D

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Infervision Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000026583
UDI-DI: 06974692710803
Basic UDI-DI: 697469271083PX
Reference: 30192180
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: Infervision Europe GmbH
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

InferRead® CT Rapid Triage

InferRead CT Rapid Triage

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Infervision Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000026583
UDI-DI: 06974692710155
Basic UDI-DI: 697469271015PE
Reference: 30192180
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: Infervision Europe GmbH
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Veolity

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: MeVis Medical Solutions AG
Manufacturer SRN: DE-MF-000005418
UDI-DI: 04260483290244
Basic UDI-DI: 0426048329VEO35
Reference: Veo-2200
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 02:01

Manufacturer products View details

04260483290268

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: MeVis Medical Solutions AG
Manufacturer SRN: DE-MF-000005418
UDI-DI: 04260483290268
Basic UDI-DI: 0426048329MVLSXH
Reference: MVLS 1.3 ROW / MVLS-View 1.3-S ROW
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 02:01

Manufacturer products View details