Medis Suite MRCT

GUDID B141MEDISSUITEMRCT210

Laboratory instrument/analyser application software IVD

Primary Device ID	B141MEDISSUITEMRCT210
NIH Device Record Key	f9c1ba7b-a3bf-49bf-b123-daf7615f04fa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Medis Suite MRCT
Version Model Number	3.0
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	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B141MEDISSUITEMRCT210 [Previous]
HIBCC	B141MEDISSUITEMRCT300 [Primary]

LLZ	System, Image Processing, Radiological

Steralize Prior To Use	false
Device Is Sterile	false

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
B141MEDISSUITEMRCT20250	Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually