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Image Management

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 839060Model 15.X

by Philips Medical Systems Nederland B.V.

Identity

Trade Name
Image Management EUDAMEDFDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
Image Management EUDAMED
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. FDA UDI
Model / Reference
15.X EUDAMEDFDA UDI
839060 EUDAMED
Description
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. FDA UDI

Identifiers

Catalog Number
839060 FDA UDI
Primary DI / UDI-DI
00884838107557 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM832TF EUDAMED
510(k) Number
K240822 FDA UDI
FDA Product Code
LLZ FDA UDI
EMDN Code
Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Medical Purpose
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. The system includes the following medical devices: Desktop Diagnostic Viewer: 839062, UDI- 00884838107571, Web Diagnostic Viewer: 839063, UDI- 00884838107588, Enterprise Viewer: 839064, UDI- 00884838107595. Each device has its own CE mark and label. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Image Management by Philips Medical Systems Nederland B.V. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.
EUDAMED SRN
NL-PR-000001565

Sources (2)

  • EUDAMED d46e4ef4-4306-40b9-952e-aef294de4e17 61 fields · synced Oct 6, 2026
  • FDA UDI fd8e6e8b-fa57-439e-b08f-f8964fd108f3 35 fields · synced May 30, 2026