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CAAS IntraVascular
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2.1Model CAAS IntraVascular510(k) K123970
Identity
- Trade Name
- CAAS IntraVascular EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- CAAS IntraVascular 2.1 EUDAMED
- Model / Reference
- CAAS IntraVascular EUDAMED2.1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304454065 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056304454065 EUDAMED
- 510(k) Number
- K123970 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CAAS IntraVascular by Pie Medical Imaging B.v. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123970 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304454065 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pie Medical Imaging B.V.
- EUDAMED SRN
- NL-MF-000001540
- FDA Applicant
- Pie Medical Imaging BV
Sources (3)
- EUDAMED d4d476c3-e991-4329-b74c-a48c75be13bb 85 fields · synced Jun 18, 2026
- FDA UDI e0fa35cb-d3f5-484e-97bd-a13c649c133f 34 fields · synced May 29, 2026
- FDA 510(k) K123970 1 fields · synced May 18, 2026