QAngio XA 3D

GUDID B141MEDISSUITEXA20190

QANGIO XA 3D is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QANGIO XA 3D enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QANGIO XA 3D provides: • Quantitative results of coronary vessel segments based on a 3D reconstructed model; • Dimensions of the cardiovascular vessels and lesions; • Quantification of the pressure drop in coronary vessels.

Medis Medical Imaging Systems B.V.

Laboratory instrument/analyser application software IVD
Primary Device IDB141MEDISSUITEXA20190
NIH Device Record Keyc5f1c0c3-676a-4488-90de-2f3eff82ec74
Commercial Distribution StatusIn Commercial Distribution
Brand NameQAngio XA 3D
Version Model Number2.0
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB141MEDISSUITEXA20190 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-05
Device Publish Date2020-01-28

Devices Manufactured by Medis Medical Imaging Systems B.V.

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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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