Identity
- Trade Name
- QAngio XA FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- QAngio XA is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats. QAngio XA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment. QAngio XA comprises functionalities for analyzing the blood vessels and the left ventricle, the right ventricle, stent and sub-segments, coronary aneurysms, and bifurcations. FDA UDI
- Model / Reference
- 7.3 FDA UDI
- Description
- QAngio XA is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats. QAngio XA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment. QAngio XA comprises functionalities for analyzing the blood vessels and the left ventricle, the right ventricle, stent and sub-segments, coronary aneurysms, and bifurcations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B141QANGIOXA730 FDA UDI
- 510(k) Number
- K112807 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laboratory instrument/analyser application software IVD
QAngio XA by Medis Medical Imaging Systems B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112807 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medis Medical Imaging Systems B.V.
Sources (1)
- FDA UDI 35971f89-3f4e-466f-abfb-2cfec8e9b3f9 35 fields · synced Jun 8, 2026