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IntelliSpace Portal Platform

by Philips Medical Systems Nederlands B.V.

510(k) K162025

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162025↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK162025 Date18 Oct 2016ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IntelliSpace Portal Platform is a picture archiving and communication system (PACS) and radiology information system (RIS) integration platform designed for managing, visualizing, and distributing medical imaging data across clinical workflows. It serves as a centralized hub for radiology, cardiology, and other imaging modalities, enabling seamless sharing of diagnostic images, reports, and patient information between healthcare providers and departments.

This platform is supplied as a software solution for integration with existing IT infrastructure in radiology and cardiology departments, supporting both single-user and multi-user environments. It is intended for use in clinical settings where radiologists, cardiologists, and other specialists require efficient access to imaging studies and related data. The system is not single-use and operates in a non-sterile environment, with regulatory authorizations including FDA 510(k) clearance (K162025) and MDD compliance under the Philips Medical Systems Nederlands B.V. brand.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical imaging data can the IntelliSpace Portal Platform manage and share across clinical workflows?

    The IntelliSpace Portal Platform is designed to manage, visualize, and distribute medical imaging data from radiology and cardiology departments, including diagnostic images, reports, and patient information. It integrates with existing IT infrastructure to enable seamless sharing between healthcare providers and departments, ensuring efficient access to imaging studies for specialists like radiologists and cardiologists.

  • Is the IntelliSpace Portal Platform intended for single-use or repeated use in clinical settings?

    The IntelliSpace Portal Platform is not a single-use device. It operates as a software solution within a non-sterile environment, allowing continuous use in clinical settings like radiology and cardiology departments for managing and sharing imaging data across workflows.

  • How is the IntelliSpace Portal Platform supplied, and what environments does it support?

    The IntelliSpace Portal Platform is supplied as a software solution that integrates with existing IT infrastructure in radiology and cardiology departments. It supports both single-user and multi-user environments, making it adaptable to various clinical settings where imaging data needs to be accessed and shared efficiently.

  • What regulatory pathways has the IntelliSpace Portal Platform undergone, and which advisory committee was involved?

    The IntelliSpace Portal Platform has received FDA 510(k) clearance under the traditional pathway, with a clearance number of K162025. It was reviewed by the Radiology (RA) Advisory Committee and is also compliant with the Medical Device Directive (MDD) under Philips Medical Systems Nederlands B.V. The decision was determined to be substantially equivalent (SESE) to a predicate device.