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Illumeo

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Nederland B.V.

Identity

Trade Name
Illumeo FDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Device Name
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context. FDA UDI
Model / Reference
v2.2 FDA UDI
Description
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context. FDA UDI

Identifiers

Catalog Number
45980163324X FDA UDI
Primary DI / UDI-DI
00884838093997 FDA UDI
510(k) Number
K173588 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA 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

Category: Radiology picture archiving and communication system workstation

Illumeo by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system workstation.

Cleared under the same submission

K173588 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.

Sources (1)

  • FDA UDI 9ea7ec37-9ef3-46da-bb9b-33a7b5644ea2 36 fields · synced Oct 6, 2026