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CAAS Workstation 8.5.3

by Pie Medical Imaging B.V.

Ref 8.5

CAAS Workstation 8.5.3 is a medical device (EU MDR Class IIb; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pie Medical Imaging B.V., registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 805630445CAASworkst5A), cleared under FDA 510(k) K180019 on 3 May 2018 and listed in FDA GUDID since 3 Nov 2022 (UDI-DI 08056304455314), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805630445CAASworkst5A Basic UDI-DI 08056304455314UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056304455314 UDI-DI Date3 Nov 2022ListedStatusListed 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 805630445CAASworkst5A registered 15 Jun 2026 Active
  • FDA 510(k) K180019 decided 3 May 2018 Active
  • FDA GUDID UDI-DI 08056304455314 listed 3 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180019
  2. Listed FDA GUDID 08056304455314
  3. Registered EUDAMED 805630445CAASworkst5A

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CAAS Workstation
Generic name
Radiology DICOM image processing application software
Model / reference
8.5 EUDAMED
8.5.3 GUDID
Primary DI / UDI-DI
08056304455314
Basic UDI-DI
805630445CAASworkst5A
Direct marketing DI
08056304455314
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 IIb EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8.5
GUDID
8.5.3
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Radiology DICOM image processing application software

Cleared under the same submission (K180019)

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 (22, all answered No)