QAngio XA 3D

Basic Information

• Brand Name: QAngio XA 3D
• Primary DI: B141MEDISSUITEXA20190
• Version / Model: 2.0
• Company Name: Medis Medical Imaging Systems B.V.
• Labeler DUNS: 549961191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-28
• Public Version: 2
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: c5f1c0c3-676a-4488-90de-2f3eff82ec74

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B141MEDISSUITEXA20190	HIBCC