QAngio XA

GUDID B141QANGIOXA730

QAngio XA is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambe

Medis Medical Imaging Systems B.V.

Laboratory instrument/analyser application software IVD
Primary Device IDB141QANGIOXA730
NIH Device Record Key35971f89-3f4e-466f-abfb-2cfec8e9b3f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameQAngio XA
Version Model Number7.3
Company DUNS549961191
Company NameMedis Medical Imaging Systems B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl
Phone+31715241700
Emailsupport@medis.nl

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB141QANGIOXA730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-13

Devices Manufactured by Medis Medical Imaging Systems B.V.

B141MEDISSUITEMRCT20230 - Medis Suite MRCT2023-06-13 Medis Suite MRCT 2023 is indicated for use in clinical settings where more reproducible than manually derived quantified results
B141MEDISSUITEXA20230 - Medis Suite XA2023-06-13 Medis Suite XA 2023 is indicated for use in clinical settings where validated and reproducible quantified results are needed to
B141MEDISSUITEMRCT20220 - Medis Suite MRCT2022-05-24 Medis Suite MRCT 2022 is indicated for use in clinical settings where more reproducible than manually derived quantified results
B141MEDISSUITEXA20220 - Medis Suite XA2022-05-24 Medis Suite XA 2022 is indicated for use in clinical settings where validated and reproducible quantified results are needed to
B141MEDISSUITEMRCT20210 - Medis Suite MRCT2021-10-19 Medis Suite MRCT 2021 is indicated for use in clinical settings where more reproducible than manually derived quantified results
B141MEDISSUITEXA20210 - Medis Suite XA2021-10-19 Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to suppo
B141MEDISSUITEMRCT20200 - Medis Suite MRCT2020-09-21 Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually derived quantified results are
B141MEDISSUITEXA20200 - Medis Suite XA2020-09-21 Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to suppo

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