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 ID: B141MEDISSUITEXA20190
• NIH Device Record Key: c5f1c0c3-676a-4488-90de-2f3eff82ec74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QAngio XA 3D
• Version Model Number: 2.0
• Company DUNS: 549961191
• Company Name: Medis Medical Imaging Systems B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B141MEDISSUITEXA20190 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-05
• Device Publish Date: 2020-01-28

Devices Manufactured by Medis Medical Imaging Systems B.V.

• B141MEDISSUITEMRCT20230 - Medis Suite MRCT: 2023-06-13 Medis Suite MRCT 2023 is indicated for use in clinical settings where more reproducible than manually derived quantified results
• B141MEDISSUITEXA20230 - Medis Suite XA: 2023-06-13 Medis Suite XA 2023 is indicated for use in clinical settings where validated and reproducible quantified results are needed to
• B141MEDISSUITEMRCT20220 - Medis Suite MRCT: 2022-05-24 Medis Suite MRCT 2022 is indicated for use in clinical settings where more reproducible than manually derived quantified results
• B141MEDISSUITEXA20220 - Medis Suite XA: 2022-05-24 Medis Suite XA 2022 is indicated for use in clinical settings where validated and reproducible quantified results are needed to
• B141MEDISSUITEMRCT20210 - Medis Suite MRCT: 2021-10-19 Medis Suite MRCT 2021 is indicated for use in clinical settings where more reproducible than manually derived quantified results
• B141MEDISSUITEXA20210 - Medis Suite XA: 2021-10-19 Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to suppo
• B141MEDISSUITEMRCT20200 - Medis Suite MRCT: 2020-09-21 Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually derived quantified results are
• B141MEDISSUITEXA20200 - Medis Suite XA: 2020-09-21 Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to suppo