Medis Suite MRCT

Organization name

Medis Medical Imaging Systems bv

SRN

NL-MF-000002670

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

Primary placement in Netherlands; available across 20 countries total.

Trade name

Medis Suite MRCT

UDI-DI code

B141MEDISSUITEMRCT2025

Basic UDI-DI

B-B141MEDISSUITEMRCT2025

Reference / catalog number

20250203

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Medis Suite MRCT 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 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 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 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.

Additional information URL

https://www.medisimaging.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

B141MEDISSUITEMRCT2025

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11030592RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE