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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

XR PACS imagepro 8 — Class IIb MDR by D.A.T.A. Corporation

MD Atlas
D.A.T.A. Corporation

EUDAMED last updated this device on May 7, 2026

XR PACS imagepro 8

912012462IMAGEPRO80JW

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: D.A.T.A. Corporation
UDI-DI code: 09120124620012
Reference / catalog number: XR PACS imagepro 8

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Manufacturer information

Organization name: D.A.T.A. Corporation
SRN: AT-MF-000017422
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Jan 1, 2026	Oct 8, 2030

Device identification

Trade name: not provided
UDI-DI code: 09120124620012
Basic UDI-DI: 912012462IMAGEPRO80JW
Reference / catalog number: XR PACS imagepro 8
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: XR PACS imagepro 8 ist eine Software zur Verarbeitung, Darstellung, Messung und Dokumentation von DICOM konformen Bildern und Zusatzinformationen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

1000208388Issued
Quality management systemNotified body: 0297Expiry: Oct 8, 2030