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CAAS Qardia 1.1

by Pie Medical Imaging B.V.

Ref 1.1

CAAS Qardia 1.1 is a device classified as Class IIb in the EU and Class II in the US made by Pie Medical Imaging B.V., registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 805630445CAASqrdLS), cleared under FDA 510(k) K212376 on 16 May 2022 and listed in FDA GUDID since 13 Jan 2023 (UDI-DI 08056304454768), withdrawn (EUDAMED), active (FDA 510(k)) as of 25 Oct 2026.

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 Withdrawn in European Union.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

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212376

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805630445CAASqrdLS Basic UDI-DI 08056304454768UDI-DIDate15 Jun 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number08056304454768 UDI-DI Date13 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK212376 Date16 May 2022IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805630445CAASqrdLS registered 15 Jun 2026 Withdrawn
  • FDA 510(k) K212376 decided 16 May 2022 Active
  • FDA GUDID UDI-DI 08056304454768 listed 13 Jan 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212376
  2. Listed FDA GUDID 08056304454768
  3. Registered EUDAMED 805630445CAASqrdLS

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CAAS Qardia
Generic name
Radiology DICOM image processing application software
Model / reference
1.1
Primary DI / UDI-DI
08056304454768
Basic UDI-DI
805630445CAASqrdLS
Direct marketing DI
08056304454768
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
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 (K212376)

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)