Viz ICH

GUDID 00811852030165

Viz ICH 1.3

VIZ.AI, INC.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software 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