Medis Suite XA

Basic Information

• Brand Name: Medis Suite XA
• Primary DI: B141MEDISSUITEXA20200
• Version / Model: 2020
• 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: 2020-09-11
• Public Version: 2
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 2ece4459-b625-4ea4-a02f-f999e5d1ae5a

Device Description

Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. XA2D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. XA3D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

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	B141MEDISSUITEXA20200	HIBCC
Previous	B141MEDISSUITEXA20190	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]