DEVICE: QAngio XA (B141QANGIOXA730)

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Device Identifier (DI) Information

QAngio XA
7.3

Medis Medical Imaging Systems B.V.
B141QANGIOXA730
HIBCC
1
QAngio XA is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats. QAngio XA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment. QAngio XA comprises functionalities for analyzing the blood vessels and the left ventricle, the right ventricle, stent and sub-segments, coronary aneurysms, and bifurcations.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Laboratory analyser application software IVD An individual software program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to an analyser or an analyser system. A basic set of applications programs and routines is included with such computer-controlled analysers and they can be modified or upgraded to correct programming errors or to add new analyser/system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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FDA Product Code

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Product Code Product Code Name
LLZ System, Image Processing, Radiological
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
June 13, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Yes
No CLOSE

Customer Contact

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+31715241700
support@medis.nl
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