AccessGUDID - DEVICE: Medis Suite MRCT (B141MEDISSUITEMRCT20180)

GUDID

Device Identifier (DI) Information

Brand Name: Medis Suite MRCT
Version or Model: 2018
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medis Medical Imaging Systems B.V.

Primary DI Number: B141MEDISSUITEMRCT20180
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 549961191 *Terms of Use
Previous DI: B141MEDISSUITEMRCT300

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. Medis Suite MRCT is intended to support the following visualization functionalities: - cine loop and 2D review - double oblique review - 3D review by means of MIP and volume rendering - 3D reformatting - performing caliper measurements Medis Suite MRCT is also intended to support the following analyses: - cardiac function quantification - MR velocity-encoded flow quantification - anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing - MR parametric maps (such as T1, T2, T2* relaxation) 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d03f7bab-a9b1-4ed1-8ada-853bc6e2e6f9
Public Version Date: March 22, 2022
Public Version Number: 2
DI Record Publish Date: August 07, 2018