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230 device results listed.

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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

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

BoneXpert

3.2

Class IMDDOn the market

Manufacturer: Visiana ApS
Manufacturer SRN: DK-MF-000029049
UDI-DI: D-574400661BONEXPERTH94K
Basic UDI-DI: B-574400661BONEXPERTH94K
Reference: 3.2
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:49

Manufacturer products View details

PMA.core

PMA.core 3.0

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Pathomation BV
Manufacturer SRN: BE-MF-000035661
UDI-DI: D-54199804460PMAcore34C59
Basic UDI-DI: B-54199804460PMAcore34C59
Reference: PMA.core 3.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 17.07.2026 02:47

Manufacturer products View details

Xeleris V Processing & Review System

Xeleris V Processing and Review System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00198953246405
Basic UDI-DI: 8406821BUG00344HF
Reference: 6015087
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Blackford Accept Reject Tool

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Blackford Analysis Limited
Manufacturer SRN: UK-MF-000044937
UDI-DI: 05060570830334
Basic UDI-DI: 50605VIEWERSMK
Reference: BART001
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Norway
Authorised representative: Advena Limited
Last updated: 16.07.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

Image Management

15.X

Class IIbMDR 2017/745On the market

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-PR-000001565
UDI-DI: 00884838107557
Basic UDI-DI: 0884838BM832TF
Reference: 839060
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 07:22

Manufacturer products View details

00861625000437

Reveal Family

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Ceevra, Inc.
Manufacturer SRN: US-MF-000042119
UDI-DI: 00861625000437
Basic UDI-DI: 08616250004reveal3A
Reference: Reveal 3
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

qER-NCCT

qSuite

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Qure.ai Technologies Private Limited
Manufacturer SRN: IN-MF-000018096
UDI-DI: 00860005118120
Basic UDI-DI: 08600051181qER-NCCTTL
Reference: v1.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Advena Limited
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

00853341006701

4.x

Class IIbMDR 2017/745On the marketActive device

Manufacturer: HeartFlow, Inc.
Manufacturer SRN: US-MF-000020729
UDI-DI: 00853341006701
Basic UDI-DI: 0853341006FFRCTSW
Reference: Heartflow Analysis v4.x
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

syngo Dynamics

MDR_05_IIb_FOR AG S3_syngo Dynamics

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151034202
Basic UDI-DI: 0405686902381VS
Reference: 11708404
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details

Syngo Carbon Space

MDR_DnA_IIb_SHS_AG_SAMD_SPACE

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151064551
Basic UDI-DI: 0405686902372VR
Reference: 11926807
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details

AI-Rad Companion (Pulmonary)

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869996172
Basic UDI-DI: 0405686902222V5
Reference: 11665780
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details

AI-Rad Companion Prostate MR

MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869298191
Basic UDI-DI: 0405686902009V3
Reference: 11582981
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

syngo.via WebViewer

MDR_05_FOR_SYNGO_SaMD_IIb

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869237626
Basic UDI-DI: 0405686901978WU
Reference: 11461434
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details