Medis Suite MRCT - Medis Suite MRCT 2022 is indicated for use in - Medis Medical Imaging Systems B.V.

Duns Number:549961191

Device Description: Medis Suite MRCT 2022 is indicated for use in clinical settings where more reproducible th Medis Suite MRCT 2022 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 2022 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2022 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 2022 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.

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More Product Details

Catalog Number

-

Brand Name

Medis Suite MRCT

Version/Model Number

2022

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

807be8dc-d338-4d4d-93b6-c30144274b63

Public Version Date

May 24, 2022

Public Version Number

1

DI Record Publish Date

May 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDIS MEDICAL IMAGING SYSTEMS B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14