Data / Medical devices / United States / Viz.ai, Inc.

Viz.ai, Inc.: FDA-registered device maker in Cary, NC, United States, 10 510(k) clearances

Name: Viz.ai, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Viz.ai, Inc. is registered with the FDA (registration 3014678441) in Cary, NC, United States. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 10, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014678441
Address: 5000 Center Green Way, Cary, NC, United States, 27513
Owner or operator: Viz.ai, Inc. (10057967)
Roles: Complaint file establishment, Specification developer
First device listed: February 18, 2019
Registered through: 2026
Brand names listed: Viz AAA, Viz ANEURYSM, Viz ANX, Viz CTP, Viz HCM, Viz HDS, Viz ICH, Viz ICH PLUS and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cardiovascular Machine Learning-Based Notification Software	QXO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radiological Computer-Assisted Prioritization Software For Lesions	QFM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 10, 2025	K250354	Viz Subdural+, Viz SUBDURAL PLUS	QIH	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
February 5, 2024	K232363	Viz HDS, Viz Volume Plus, Viz ICH+	QIH	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
August 3, 2023	DEN230003	Viz HCM	QXO	Unknown	Viz. Ai, Inc.	accessdata.fda.gov
March 17, 2023	K223443	Viz AAA	QFM	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
October 21, 2022	K223042	Viz LVO ContaCT	QAS	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
August 29, 2022	K221100	Viz RV/LV	QIH	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
July 25, 2022	K220439	Viz SDH	QAS	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
February 18, 2022	K213319	Viz ANEURYSM, Viz ANX	QFM	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
March 23, 2021	K210209	Viz ICH	QAS	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov
April 20, 2018	K180161	Viz CTP	LLZ	Substantially Equivalent	Viz. Ai, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.