CAAS Qardia
Ref 1.0Model CAAS Qardia
CAAS Qardia (1.0) is a medical device (EU MDD Class IIa) made by Pie Medical Imaging B.V., registered in EUDAMED on 27 Sep 2022 (Basic UDI-DI B-08056304454355) and cleared under FDA 510(k) K212376 on 16 May 2022, active as of 24 Oct 2026.
Active
CE MDD 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-08056304454355 08056304454355 | Date27 Sep 2022 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK212376 | Date16 May 2022 | StatusActive |
Official records
- EUDAMED public site B-08056304454355
- FDA 510(k) database K212376
Across registries
- EUDAMED Basic UDI-DI B-08056304454355 registered 27 Sep 2022 Active
- FDA 510(k) K212376 decided 16 May 2022 Active
Timeline
- Cleared FDA 510(k) K212376
- Registered EUDAMED B-08056304454355
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Device name
- CAAS Qardia 1.0
- Model / reference
- CAAS Qardia, 1.0
- Primary DI / UDI-DI
- 08056304454355
- Basic UDI-DI
- B-08056304454355
- EMDN code
- Z11039082 Various radiodiagnostic and interventional instruments - software accessories
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000001540
Similar devices in this category
Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES.
- CAAS Workstation 8.5.3 by Pie Medical Imaging B.V.
- ARES ARES - AS8004 by Ares Medikal Sanayi Ticaret Ltd. Şti.
- ADAS3D ADAS 3D by ADAS3D MEDICAL S.L.
- Caas Qardia 2.1 by Pie Medical Imaging B.V.
- ChestView by Gleamer Sas
- SMOP 07649997938014 by Swissmeda AG
- ARES ARES - AS8003 by Ares Medikal Sanayi Ticaret Ltd. Şti.
- CAD4TBBox by Delft Imaging Systems B.V.
- BoneView by Gleamer Sas