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AI-Rad Companion Chest CT

MDR_05_IIb_FOR_SAMD_AIRC_CT

Class IIbMDR 2017/745On the market

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151087901
Basic UDI-DI: 0405686902380VQ
Reference: 11926838
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

AI-Rad Companion Chest X-ray

MDR_SAMD_05_IIb_FOR_AIRC_CxR

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151085136
Basic UDI-DI: 0405686902373VT
Reference: 11926818
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

AI-Rad Companion Chest CT

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT

Class IIbMDR 2017/745On the market

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151045260
Basic UDI-DI: 0405686902356VT
Reference: 11830632
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

AI Contouring

AI Contouring Family

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151048117
Basic UDI-DI: 0405686902368W2
Reference: 10831446
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

AI-Rad Companion Organs RT

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151010404
Basic UDI-DI: 0405686902011UN
Reference: 11823875
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

AI-Rad Companion Chest X-ray

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151009774
Basic UDI-DI: 0405686902195VT
Reference: 11823189
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

AI-Rad Companion Prostate MR

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151000887
Basic UDI-DI: 0405686902009V3
Reference: 11666038
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

Syngo Carbon Enterprise Access

MDR_05_FOR_SYNGO_SaMD_IIb

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151001075
Basic UDI-DI: 0405686901978WU
Reference: 11666036
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

04262366881037

STARC medical PACS Image Viewer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: STARC medical GmbH
Manufacturer SRN: DE-MF-000013383
UDI-DI: 04262366881037
Basic UDI-DI: 426236688STM001G4
Reference: 7.25
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:05

Manufacturer products View details

08437027816017

3DLF Scanner Max – V2

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Voxelcare S.L
Manufacturer SRN: ES-MF-000048501
UDI-DI: 08437027816017
Basic UDI-DI: 84370278163DLFSMaxVX
Reference: 3D Laser Plantar Foot Scanner Max
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Germany
Authorised representative: -
Last updated: 24.07.2026 23:11

Manufacturer products View details

08437027816000

3DLF Scanner

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Voxelcare S.L
Manufacturer SRN: ES-MF-000048501
UDI-DI: 08437027816000
Basic UDI-DI: 84370278163DLFSCompactTY
Reference: 3D Laser Plantar Foot Scanner Compact
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Germany
Authorised representative: -
Last updated: 24.07.2026 23:11

Manufacturer products View details

AMULET Bellus II

MIS-1000

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410345438
Basic UDI-DI: 454741040100000000000498V
Reference: 04547410345438
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 24.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

syngo.MI General

Image Processing Software_10_IIa_HES

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04068151009460
Basic UDI-DI: 0405686900137UX
Reference: 11589500
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: Siemens Healthineers AG
Last updated: 23.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

04049471069198

N/A

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049471069198
Basic UDI-DI: 4049471_DPS001_6B
Reference: 6919
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 23.07.2026 22:45

Manufacturer products View details

Z12120192

Class INot specifiedOn the marketActive device

Manufacturer: URAL TELEKOMÜNİKASYON SAN. TİC. A.Ş
Manufacturer SRN: TR-MF-000024209
UDI-DI: 08683079746752
Basic UDI-DI: 86830797467NVFundus5H
Reference: EyeCheckup v1
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 23.07.2026 00:38

Manufacturer products View details

CHILI PACS

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: NEXUS / CHILI GmbH
Manufacturer SRN: DE-MF-000007503
UDI-DI: 04260456230208
Basic UDI-DI: 4260456230000T5
Reference: 4.92.0
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 21.07.2026 22:49

Manufacturer products View details

Scenium

Image Processing Software_10_IIa_HES

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Medical Solutions USA, Inc.
Manufacturer SRN: US-MF-000016485
UDI-DI: 04056869950198
Basic UDI-DI: 0405686900137UX
Reference: 11431562
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: Siemens Healthcare GmbH
Last updated: 21.07.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

Rayvolve

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: AZmed
Manufacturer SRN: FR-MF-000014277
UDI-DI: 37700180712376
Basic UDI-DI: 3770018071008VP
Reference: Rayvolve - On premise (version 8)
EMDN: Z11060292
EMDN description: DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 17.07.2026 06:48

Manufacturer products View details

NOVAPACS

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Novarad Corporation
Manufacturer SRN: US-MF-000028327
UDI-DI: B109NOVAPACS8930
Basic UDI-DI: ++B109NOVAPACS5H
Reference: PAC-1000
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Rayvolve

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: AZmed
Manufacturer SRN: FR-MF-000014277
UDI-DI: 37700180712208
Basic UDI-DI: 3770018071008VP
Reference: Rayvolve - VM + Cloud (version 8)
EMDN: Z11060292
EMDN description: DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 17.07.2026 05:20

Manufacturer products View details