Viz ICH+

GUDID 00811852030349

Viz ICH+ v1.0 (2024-07-24)

VIZ.AI, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00811852030349
• NIH Device Record Key: 9665f45e-164c-4e7a-8b01-de99803a2b7c
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811852030349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232363

FDA Product Code

• QIH: Automated Radiological Image Processing 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: 2024-08-20
• Device Publish Date: 2024-08-12

Devices Manufactured by VIZ.AI, INC.

• 00811852030349 - Viz ICH+: 2024-08-20Viz ICH+ v1.0 (2024-07-24)
• 00811852030349 - Viz ICH+: 2024-08-20 Viz ICH+ v1.0 (2024-07-24)
• 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