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CAAS IntraVascular

by Pie Medical Imaging B.V. 2 variants

Ref 2.1Model CAAS IntraVascular510(k) K123970

CAAS IntraVascular (2.1) 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-08056304454065), cleared under FDA 510(k) K123970 on 6 Feb 2013 and listed in FDA GUDID since 22 Nov 2018 (UDI-DI 08056304454065), 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) K123970↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08056304454065 Basic UDI-DI 08056304454065UDI-DIDate18 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08056304454065 UDI-DI Date22 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK123970 Date6 Feb 2013ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08056304454065 registered 18 Aug 2022 Active
  • FDA 510(k) K123970 decided 6 Feb 2013 Active
  • FDA GUDID UDI-DI 08056304454065 listed 22 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123970
  2. Listed FDA GUDID 08056304454065
  3. Registered EUDAMED B-08056304454065

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  • Withdrawn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
Radiology DICOM image processing application software
Device name
CAAS IntraVascular 2.1
Model / reference
CAAS IntraVascular, 2.1
Primary DI / UDI-DI
08056304454065
Basic UDI-DI
B-08056304454065
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
FDA applicant
Pie Medical Imaging BV

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)