Medis Suite XA

GUDID B141MEDISSUITEXA20230

Medis Suite XA 2023 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA 2023 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. 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.

Medis Medical Imaging Systems B.V.

Laboratory instrument/analyser application software IVD

• Primary Device ID: B141MEDISSUITEXA20230
• NIH Device Record Key: ac95f375-ff94-497d-830c-7a2c3e1326c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medis Suite XA
• Version Model Number: 2023
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B141MEDISSUITEXA20220 [Previous]
HIBCC	B141MEDISSUITEXA20230 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-13
• Device Publish Date: 2023-06-05

On-Brand Devices [Medis Suite XA]

• B141MEDISSUITEXA20200: Medis Suite XA is indicated for use in clinical settings where validated and reproducible quanti
• B141MEDISSUITEXA20210: Medis Suite XA is indicated for use in clinical settings where validated and reproducible quanti
• B141MEDISSUITEXA20220: Medis Suite XA 2022 is indicated for use in clinical settings where validated and reproducible q
• B141MEDISSUITEXA20230: Medis Suite XA 2023 is indicated for use in clinical settings where validated and reproducible q