Medis Suite MRCT

GUDID B141MEDISSUITEMRCT20210

Medis Suite MRCT 2021 is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT 2021 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2021 can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2021 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. 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.

Medis Medical Imaging Systems B.V.

Laboratory instrument/analyser application software IVD
Primary Device IDB141MEDISSUITEMRCT20210
NIH Device Record Keyf95e1f33-1e0b-40e0-b6a5-29178a616f88
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedis Suite MRCT
Version Model Number2021
Company DUNS549961191
Company NameMedis Medical Imaging Systems B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB141MEDISSUITEMRCT20200 [Previous]
HIBCCB141MEDISSUITEMRCT20210 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-19
Device Publish Date2021-10-11

On-Brand Devices [Medis Suite MRCT]

B141MEDISSUITEMRCT210Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT
B141MEDISSUITEMRCT20180Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually
B141MEDISSUITEMRCT20200Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually
B141MEDISSUITEMRCT20210Medis Suite MRCT 2021 is indicated for use in clinical settings where more reproducible than man
B141MEDISSUITEMRCT20220Medis Suite MRCT 2022 is indicated for use in clinical settings where more reproducible than man
B141MEDISSUITEMRCT20230Medis Suite MRCT 2023 is indicated for use in clinical settings where more reproducible than man

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