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Interventional Workspot

by Philips Medical Systems Nederland B.V.

Ref 001000510(k) K181177

Active European Union and United States. Also listed in GUDID (US).

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) K181177↗

+1 more

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884838059191 Basic UDI-DI 00884838059191UDI-DIDate25 Nov 2024RegisteredStatusActive EUDAMED: not on the EU market
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK181177 Date31 May 2018ClearedStatusActive
United StatesGUDID listing GUDID Number00884838059191 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Cardiovascular fluoroscopy/intravascular imaging software
Model / Ref / Catalog
001000, Interventional Workspot - 1
Primary DI / UDI-DI
00884838059191
Basic UDI-DI
B-00884838059191
FDA Product Code
LLZ, OWB
EMDN Code
Z11030182 Digital angiography systems - software accessories
GMDN Term
Cardiovascular fluoroscopy/intravascular imaging software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050, 892.1650
Special Device Type
-1192
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
001000
GUDID
Interventional Workspot - 1
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

Other properties (21)

  • 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
  • Manufacturing Date: No