Medis Suite MRCT

Primary DI
B141MEDISSUITEMRCT20180
Brand
Medis Suite MRCT
Company
Medis Medical Imaging Systems B.V.
Model
2018
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 fluidThese 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.
Published
2018-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B141MEDISSUITEMRCT300PreviousHIBCC0
B141MEDISSUITEMRCT20180PrimaryHIBCC0
B141MEDISSUITEMRCT20190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
549961191
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B141QIVUS300QIvus3.02026-04-21
B141MEDISSUITEMRCT20250Medis Suite MRCT20252025-05-14
B141MEDISSUITEMRCT20230Medis Suite MRCT20232023-06-05
B141MEDISSUITEXA20230Medis Suite XA20232023-06-05
B141MEDISSUITEMRCT20220Medis Suite MRCT20222022-05-16
B141MEDISSUITEXA20220Medis Suite XA20222022-05-16
B141MEDISSUITEMRCT20190Medis Suite MRCT20192020-01-28
B141MEDISSUITEMRCT300Medis Suite MRCT3.02017-08-07
B141MEDISSUITEMRCT20210Medis Suite MRCT20212021-10-11
B141MEDISSUITEXA20210Medis Suite XA20212021-10-11
B141MEDISSUITEMRCT20200Medis Suite MRCT20202020-09-11
B141MEDISSUITEXA20200Medis Suite XA20202020-09-11
B141MEDISSUITEXA2D20190Medis Suite XA 2D20192020-02-20
B141MEDISSUITEXA20190QAngio XA 3D2.02020-01-28
B141MEDISSUITEMRCT210Medis Suite MRCT2.12017-03-06
B141MEDISSUITEXA2D20180Medis Suite XA 2D20182018-08-07
B141QANGIOXA730QAngio XA7.32016-06-13

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