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QAngio XA 3D

FDA UDI

Class II (US FDA UDI)

by Medis Medical Imaging Systems B.V.

Identity

Trade Name
QAngio XA 3D FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
QANGIO XA 3D is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QANGIO XA 3D enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QANGIO XA 3D provides: • Quantitative results of coronary vessel segments based on a 3D reconstructed model; • Dimensions of the cardiovascular vessels and lesions; • Quantification of the pressure drop in coronary vessels. FDA UDI
Model / Reference
2.0 FDA UDI
Description
QANGIO XA 3D is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QANGIO XA 3D enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QANGIO XA 3D provides: • Quantitative results of coronary vessel segments based on a 3D reconstructed model; • Dimensions of the cardiovascular vessels and lesions; • Quantification of the pressure drop in coronary vessels. FDA UDI

Identifiers

Primary DI / UDI-DI
B141MEDISSUITEXA20190 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 3D by Medis Medical Imaging Systems B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medis Medical Imaging Systems B.V.

Sources (1)

  • FDA UDI c5f1c0c3-676a-4488-90de-2f3eff82ec74 33 fields · synced Jun 6, 2026