Medis Suite XA 2D

GUDID B141MEDISSUITEXA2D20190

Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations 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. Medis Suite XA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports. The analysis results obtained with Medis Suite XA are intended for use by cardiologists and radiologists: • to support clinical decisions concerning the heart and vessels • to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels

Medis Medical Imaging Systems B.V.

Laboratory instrument/analyser application software IVD

• Primary Device ID: B141MEDISSUITEXA2D20190
• NIH Device Record Key: 8294adf4-32a5-428d-b5da-04287d323d31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medis Suite XA 2D
• Version Model Number: 2019
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B141MEDISSUITEXA2D20180 [Previous]
HIBCC	B141MEDISSUITEXA2D20190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112807

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: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [Medis Suite XA 2D]

• B141MEDISSUITEXA2D20180: Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic
• B141MEDISSUITEXA2D20190: Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic