Medis Suite MRCT

Basic Information

• Brand Name: Medis Suite MRCT
• Primary DI: B141MEDISSUITEMRCT210
• Version / Model: 2.1
• 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: 2017-03-06
• Public Version: 3
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 12f05484-1e82-4438-af1b-5fada2f20ff6

Device Description

Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. This includes: - double oblique review of MR Angiographic images, - 3D review by means of MIP and volume rendering, - 3D reformatting of MR Angiographic images, and - performing caliper measurements. Medis Suite MRCT is intended to support the following visualization functionalities: - cine loop and 2D review - performing caliper measurements Medis Suite MRCT is also intended to support the following analyses: - cardiac function quantification - anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing - MR parametric maps (such as T1, T2, T2* relaxation) - MR velocity-encoded flow quantification Medis Suite MRCT is also intended to be used for: - quantification of T2* results in MR images that can be used to characterize iron loading in the heart and the liver - MR velocity-encoded flow quantification of cerebral spinal fluid These analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. The results obtained are displayed on top of the images and provided in reports. The analysis results obtained with Medis Suite MRCT are intended for use by cardiologists and radiologists: - to support clinical decisions concerning the heart and vessels, and - to support the evaluation of interventions or drug therapy applied for conditions of the heart and 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: No
• 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	B141MEDISSUITEMRCT210	HIBCC

Customer Contacts

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