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 ID: B141QANGIOXA730
• NIH Device Record Key: 35971f89-3f4e-466f-abfb-2cfec8e9b3f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QAngio XA
• Version Model Number: 7.3
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl
• Phone: +31715241700
• Email: support@medis.nl

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B141QANGIOXA730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112807

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-13

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