Viz ICH

GUDID 00811852030165

Viz ICH 1.3

VIZ.AI, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00811852030165
• NIH Device Record Key: 92bed1ba-8083-49de-aaaa-51868461cadb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viz ICH
• Version Model Number: 1.3
• Company DUNS: 080594139
• Company Name: VIZ.AI, INC.
• 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: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai
• Phone: +1(415)663-6130
• Email: greg@viz.ai

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811852030165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193658

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: 2020-04-13
• Device Publish Date: 2020-04-03

On-Brand Devices [Viz ICH]

• 00811852030165: Viz ICH 1.3
• 00811852030318: Viz ICH v1.5