Viz ICH

GUDID 00811852030318

Viz ICH v1.5

VIZ.AI, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00811852030318
• NIH Device Record Key: 4aea1295-ca5c-4d91-ad01-5392dfa57352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viz ICH
• Version Model Number: Viz ICH Software
• 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
• 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
• 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
• 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
• 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
• 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 [Previous]
GS1	00811852030318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210209

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: 2022-04-14
• Device Publish Date: 2022-04-06

On-Brand Devices [Viz ICH]

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