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 ID: B141MEDISSUITEMRCT20210
• NIH Device Record Key: f95e1f33-1e0b-40e0-b6a5-29178a616f88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medis Suite MRCT
• Version Model Number: 2021
• Company DUNS: 549961191
• Company Name: Medis Medical Imaging Systems B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B141MEDISSUITEMRCT20200 [Previous]
HIBCC	B141MEDISSUITEMRCT20210 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-19
• Device Publish Date: 2021-10-11

On-Brand Devices [Medis Suite MRCT]

• B141MEDISSUITEMRCT210: Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT
• B141MEDISSUITEMRCT20180: Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually
• B141MEDISSUITEMRCT20200: Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually
• B141MEDISSUITEMRCT20210: Medis Suite MRCT 2021 is indicated for use in clinical settings where more reproducible than man
• B141MEDISSUITEMRCT20220: Medis Suite MRCT 2022 is indicated for use in clinical settings where more reproducible than man
• B141MEDISSUITEMRCT20230: Medis Suite MRCT 2023 is indicated for use in clinical settings where more reproducible than man