Viz LVO

GUDID 00811852030042

Viz LVO 1.4

VIZ.AI, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00811852030042
• NIH Device Record Key: da3aa6fd-e1a1-46e3-baa0-55de24aaea6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viz LVO
• Version Model Number: 1.4
• 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	00811852030042 [Previous]
GS1	00811852030059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170073

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-04-09

On-Brand Devices [Viz LVO]

• 00811852030004: Viz LVO v1.1
• 00811852030035: Viz LVO 1.3
• 00811852030042: Viz LVO 1.4
• 00811852030059: Viz LVO 1.5
• 00811852030073: Viz LVO 1.6
• 00811852030080: Viz LVO 1.7
• 00811852030110: Viz LVO 1.9
• 00811852030097: Viz LVO 1.8
• 00811852030172: Viz LVO 1.10
• 00811852030189: Viz LVO 1.11
• 00811852030301: Viz LVO v1.14.1