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CAAS Workstation

by Pie Medical Imaging B.V. 7 variants

Ref 8.1Model CAAS Workstation

CAAS Workstation (8.1) is a medical device (EU MDD Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pie Medical Imaging B.V., registered in EUDAMED on 18 Aug 2022 (Basic UDI-DI B-08056304454003), cleared under FDA 510(k) K180019 on 3 May 2018 and listed in FDA GUDID since 25 Jun 2018 (UDI-DI 08056304454003), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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) K180019

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08056304454003 Basic UDI-DI 08056304454003UDI-DIDate18 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08056304454003 UDI-DI Date25 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180019 Date3 May 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08056304454003 registered 18 Aug 2022 Active
  • FDA 510(k) K180019 decided 3 May 2018 Active
  • FDA GUDID UDI-DI 08056304454003 listed 25 Jun 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180019
  2. Listed FDA GUDID 08056304454003
  3. Registered EUDAMED B-08056304454003

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  • Withdrawn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 · GUDID

Generic name
Radiology DICOM image processing application software
Device name
CAAS Workstation 8.1
Model / reference
CAAS Workstation, 8.1
Primary DI / UDI-DI
08056304454003
Basic UDI-DI
B-08056304454003
510(k) Number
FDA product code
LLZ
EMDN code
Z11039082 Various radiodiagnostic and interventional instruments - software accessories
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
NL-MF-000001540

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Pie Medical Imaging B.V.

See all devices from Pie Medical Imaging B.V. →

Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (20, all answered No)