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IQon Spectral CT

IQon Spectral CT System

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838059542
Basic UDI-DI: 0884838BM280SU
Reference: 728332
EMDN: Z11030605
EMDN description: COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 07:10

Manufacturer products View details

MX 16-slice

CT Scanner System (MX 16-slice)

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000003923
UDI-DI: 00884838059535
Basic UDI-DI: 0884838BM286T8
Reference: 728131
EMDN: Z11030603
EMDN description: COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

Ingenuity Core

Ingenuity CT System

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838059498
Basic UDI-DI: 0884838BM279TB
Reference: 728321
EMDN: Z11030601
EMDN description: COMPUTED TOMOGRAPHS - NOT EXCEEDING 2 LAYERS
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:10

Manufacturer products View details

Brilliance iCT

BRILLIANCE iCT SYSTEM

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838059474
Basic UDI-DI: 0884838BM278T9
Reference: 728306
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:10

Manufacturer products View details

BV Endura

Class IIbMDR 2017/745No longer on the marketActive deviceMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838055490
Basic UDI-DI: 0884838BM346SZ
Reference: 718075
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:10

Manufacturer products View details

IQQA®-BodyImaging, IQQA-BodyImaging

IQQA®-BodyImaging

Class IIaMDR 2017/745On the marketActive device

Manufacturer: EDDA Technology, Inc.
Manufacturer SRN: US-MF-000050953
UDI-DI: 00868466000220
Basic UDI-DI: 08684660002BI01RA
Reference: IQQA-BodyImaging
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

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EG6500

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Webb Medical LLC
Manufacturer SRN: US-MF-000055480
UDI-DI: 00868040000301
Basic UDI-DI: 08680400003EG6500E9
Reference: EG6500
EMDN: Z11030585
EMDN description: RADIOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

00860010893203

1.0

Class IMDR 2017/745On the marketDirect marking

Manufacturer: VELMENI Inc.
Manufacturer SRN: US-MF-000046518
UDI-DI: 00860010893203
Basic UDI-DI: 086001089321.0FT
Reference: V4D1.0
EMDN: Z11030392
EMDN description: INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Freyr Life Sciences GmbH
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

eKare inSight

EK001

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: eKare Inc.
Manufacturer SRN: US-MF-000004864
UDI-DI: 00860003459850
Basic UDI-DI: 08600034598EK001EE
Reference: EK001
EMDN: Z11039003
EMDN description: MULTIFORMAT CAMERAS
First on market country: Netherlands
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Image Receptor Positioner

Class IMDR 2017/745On the market

Manufacturer: Reina Imaging
Manufacturer SRN: US-MF-000008652
UDI-DI: 00860001700121
Basic UDI-DI: 08600017001IRPositionerXB
Reference: Image Receptor Positioner
EMDN: Z110310
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY
First on market country: Italy
Authorised representative: Meddevices Lifesciences B.V.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Image Receptor Protector

Class IMDR 2017/745On the market

Manufacturer: Reina Imaging
Manufacturer SRN: US-MF-000008652
UDI-DI: 00860001700183
Basic UDI-DI: 08600017001IRProtector52
Reference: Image Receptor Protector
EMDN: Z110310
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY
First on market country: Italy
Authorised representative: Meddevices Lifesciences B.V.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Positioner

Class IMDR 2017/745On the market

Manufacturer: Reina Imaging
Manufacturer SRN: US-MF-000008652
UDI-DI: 00860001700176
Basic UDI-DI: 08600017001PPositionerU8
Reference: Patient Positioner
EMDN: Z110310
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY
First on market country: Italy
Authorised representative: Meddevices Lifesciences B.V.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

00860000171298

1.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Subtle Medical, Inc.
Manufacturer SRN: US-MF-000032747
UDI-DI: 00860000171298
Basic UDI-DI: 08600001712AiMIFY13H
Reference: 1.x
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

00860000171243

1.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Subtle Medical, Inc.
Manufacturer SRN: US-MF-000032747
UDI-DI: 00860000171243
Basic UDI-DI: 08600001712SubtleHD1XV
Reference: 1.x
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

00860000171229

1.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Subtle Medical, Inc.
Manufacturer SRN: US-MF-000032747
UDI-DI: 00860000171229
Basic UDI-DI: 08600001712SubtleSYNTH1KR
Reference: 1.x
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

SubtleMR (Software as a Service for post-processing of Magnetic Resonance data)

2.x

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Subtle Medical, Inc.
Manufacturer SRN: US-MF-000032747
UDI-DI: 00860000171212
Basic UDI-DI: 08600001712SubtleMR225
Reference: 2.x
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

SubtlePET (Software as a Service for post-processing of Positron Emission Tomography data)

2.x

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Subtle Medical, Inc.
Manufacturer SRN: US-MF-000032747
UDI-DI: 00860000171205
Basic UDI-DI: 08600001712SubtlePET2B3
Reference: 2.x
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

00854344007719

Digital Image Receptors -Stationary

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Varex Imaging Corporation
Manufacturer SRN: US-MF-000028124
UDI-DI: 00854344007719
Basic UDI-DI: 0854344007Img_ReceptorSJM
Reference: Digital Image Receptors -Stationary
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Arazy Group GmbH
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

00854344007702

Digital Image Receptors - Portable

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Varex Imaging Corporation
Manufacturer SRN: US-MF-000028124
UDI-DI: 00854344007702
Basic UDI-DI: 0854344007Img_ReceptorPJF
Reference: Digital Image Receptors - Portable
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Arazy Group GmbH
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

Nexus DR

Varex Nexus DR Digital X-ray Imaging System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Varex Imaging Corporation
Manufacturer SRN: US-MF-000028124
UDI-DI: 00854344007030
Basic UDI-DI: 08543440070187
Reference: i5
EMDN: Z11030599
EMDN description: RADIOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Arazy Group GmbH
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details