Medis Suite XA 2D - Medis Suite XA is software intended to be used - Medis Medical Imaging Systems B.V.

Duns Number:549961191

Device Description: Medis Suite XA is software intended to be used for performing calculations in X-ray angiog 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

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More Product Details

Catalog Number

-

Brand Name

Medis Suite XA 2D

Version/Model Number

2019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112807,K112807

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

8294adf4-32a5-428d-b5da-04287d323d31

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

February 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDIS MEDICAL IMAGING SYSTEMS B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14