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IntelliSpace Cardiovascular 8

by Philips Medical Systems Nederland B.V.

Ref 830089Model IntelliSpace Cardiovascular

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

1 Jul 2030

CE MDR certificate

FDA recalls

3 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2243163CE01 Date20 Jan 2026IssuedStatusActive expires 1 Jul 2030
United StatesGUDID listing GUDID Number00884838122000 UDI-DI Date30 Apr 2024ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243163CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    20 Jan 2026
    Expires
    1 Jul 2030
    Reason
    Add device or group

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2543-2025 FDA Class II initiated 8 Aug 2025

    Software issue that results in the display of outdated information.

    • Ongoing Z-1740-2025 FDA Class II initiated 7 Apr 2025

    An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

    • Ongoing Z-1252-2025 FDA Class II initiated 4 Apr 2024

    Study data is not able to be archived, copied, or exported with the cardiovascular software version.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
IntelliSpace Cardiovascular 8 EUDAMED
IntelliSpace Cardiovascular GUDID
Generic Name
Radiology picture archiving and communication system workstation
Model / Ref / Catalog
IntelliSpace Cardiovascular, 830089, 8
Primary DI / UDI-DI
00884838122000
Basic UDI-DI
0884838BM535T6
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z110603 Picture archiving and communication systems
GMDN Term
Radiology picture archiving and communication system workstation
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
IntelliSpace Cardiovascular
830089
GUDID
8
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No