StrokeViewer LVO detection

GUDID 08720299502338

StrokeViewer LVO detection is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.

NICo-Lab B.V.

X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software

• Primary Device ID: 08720299502338
• NIH Device Record Key: 82b2ff9c-a0b8-4072-b924-b2f7ad86db8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrokeViewer LVO detection
• Version Model Number: 3.1
• Company DUNS: 491812076
• Company Name: NICo-Lab 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com
• Phone: +31202440852
• Email: support@nicolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720299502338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200873

FDA Product Code

• QAS: Radiological Computer-Assisted Triage And Notification Software

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: 2022-03-16
• Device Publish Date: 2022-03-08

Devices Manufactured by NICo-Lab B.V.

• 08720299502352 - StrokeViewer Perfusion: 2023-12-28 StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion i
• 08720299502338 - StrokeViewer LVO detection: 2022-03-16StrokeViewer LVO detection is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
• 08720299502338 - StrokeViewer LVO detection: 2022-03-16 StrokeViewer LVO detection is a notification only cloud-based image processing software application using artificial intelligenc