Duns Number:549961191
Device Description: Medis Suite MRCT is software intended to be used for the visualization and analysis of MR 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. This includes:- double oblique review of MR Angiographic images,- 3D review by means of MIP and volume rendering,- 3D reformatting of MR Angiographic images, and- performing caliper measurements. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)- MR velocity-encoded flow quantificationMedis 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, and- to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels.
Catalog Number
-
Brand Name
Medis Suite MRCT
Version/Model Number
2.1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
12f05484-1e82-4438-af1b-5fada2f20ff6
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
March 06, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 14 |