QAngio XA

Primary DI
B141QANGIOXA730
Brand
QAngio XA
Company
Medis Medical Imaging Systems B.V.
Model
7.3
Device description
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.
Published
2016-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112807000X-RAY VVAMedis Medical Imaging Systems BV2012-02-27LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B141QANGIOXA730PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31715241700support@medis.nl

Regulatory Flags#

DUNS number
549961191
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

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B141MEDISSUITEMRCT20220Medis Suite MRCT20222022-05-16
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B141MEDISSUITEMRCT20190Medis Suite MRCT20192020-01-28
B141MEDISSUITEMRCT300Medis Suite MRCT3.02017-08-07
B141MEDISSUITEMRCT20210Medis Suite MRCT20212021-10-11
B141MEDISSUITEXA20210Medis Suite XA20212021-10-11
B141MEDISSUITEMRCT20200Medis Suite MRCT20202020-09-11
B141MEDISSUITEXA20200Medis Suite XA20202020-09-11
B141MEDISSUITEXA2D20190Medis Suite XA 2D20192020-02-20
B141MEDISSUITEXA20190QAngio XA 3D2.02020-01-28
B141MEDISSUITEMRCT20180Medis Suite MRCT20182018-08-07
B141MEDISSUITEMRCT210Medis Suite MRCT2.12017-03-06
B141MEDISSUITEXA2D20180Medis Suite XA 2D20182018-08-07

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