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Medis Suite MRCT

FDA UDI

Class II (US FDA UDI)

by Medis Medical Imaging Systems B.V.

Identity

Trade Name
Medis Suite MRCT FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
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 quantification 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 fluid These 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. FDA UDI
Model / Reference
2.1 FDA UDI
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. 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 quantification 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 fluid These 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. FDA UDI

Identifiers

Primary DI / UDI-DI
B141MEDISSUITEMRCT210 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laboratory instrument/analyser application software IVD

Medis Suite MRCT by Medis Medical Imaging Systems B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medis Medical Imaging Systems B.V.

Sources (1)

  • FDA UDI 12f05484-1e82-4438-af1b-5fada2f20ff6 34 fields · synced May 30, 2026