StrokeViewer Perfusion

GUDID 08720299502352

StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients.

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

• Primary Device ID: 08720299502352
• NIH Device Record Key: ba52c775-c1f6-4ea9-bf39-cf4c5d934982
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrokeViewer Perfusion
• Version Model Number: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720299502352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231570

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: 2023-12-28
• Device Publish Date: 2023-12-20

Devices Manufactured by NICo-Lab B.V.

• 08720299502352 - StrokeViewer Perfusion: 2023-12-28StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients.
• 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: 2022-03-16 StrokeViewer LVO detection is a notification only cloud-based image processing software application using artificial intelligenc