Viz HCM

GUDID 00811852030332

Viz HCM v1.0 (2023-09-04)

VIZ.AI, INC.

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• Primary Device ID: 00811852030332
• NIH Device Record Key: 9619ed9e-8888-4cec-8d3b-a0a37ef9ce8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viz HCM
• Version Model Number: Viz HCM 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811852030332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN230003

FDA Product Code

• QXO: Cardiovascular Machine Learning-Based 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: 2023-09-18
• Device Publish Date: 2023-09-08

Devices Manufactured by VIZ.AI, INC.

• 00811852030332 - Viz HCM: 2023-09-18Viz HCM v1.0 (2023-09-04)
• 00811852030332 - Viz HCM: 2023-09-18 Viz HCM v1.0 (2023-09-04)
• 00811852030325 - Viz AAA: 2023-05-30 Viz AAA v1.0 (2023-05-08)
• 00811852030295 - Viz RV/LV: 2023-04-21 Viz RV/LV v1.2 (2023-04-19)
• 00811852030271 - Viz SDH (Viz Sudural): 2023-03-09 Viz SDH v1.3 (2023-03-06)
• 00811852030196 - Viz ANEURYSM: 2022-07-13 Viz ANEURYSM v1.3
• 00811852030301 - Viz LVO: 2022-04-14 Viz LVO v1.14.1
• 00811852030318 - Viz ICH: 2022-04-14 Viz ICH v1.5
• 00811852030288 - Viz CTP: 2022-03-23 Viz CTP v1.8