Skip to content

IntelliSpace Portal - 10

by Philips Medical Systems Nederland B.V.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838086449 UDI-DI Date31 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
IntelliSpace Portal
Generic Name
Radiology DICOM image processing application software
Model / Ref / Catalog
IntelliSpace Portal - 10, 45980131596X
Primary DI / UDI-DI
00884838086449
510(k) Number
FDA Product Code
LLZ
GMDN Term
Radiology DICOM image processing application software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K162025)

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No