Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014678441

FEI Number

3014678441

Entity Name

VIZ.AI, INC.

City/State/Country

Cary, NC, US

Establishment Address

5000 Center Green Way, Cary, NC 27513, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Viz.ai, Inc. (Owner Number: 10057967)

Owner / Operator Contact Address

548 Market St #21826, San Francisco, CA 94104, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221100

PMA Number

N/A

All Registered Proprietary Names

Viz ICH Viz AAA Viz HDS Viz VOLUME PLUS Viz ICH PLUS Viz ICH+ Viz SDH Measurements Viz SDH Collections Viz Subdural+ Viz Subdural Measurements Viz SDH Plus Viz Subdural Plus Viz Subdural Collections Viz SDH+ Viz LVO Viz ANEURYSM Viz ANX Viz RV/LV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2021-05-11
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2023-05-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-02-07
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-06-23
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-06-07
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2022-03-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-10-19

Official Correspondent

Gregory Ramina

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Viz.ai, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014665798	Viz.ai Israel Ltd	Tel Aviv, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220709	Aidoc Medical , Ltd.	BriefCase	2022-10-07
K190362	Zebra Medical Vision, Ltd.	HealthPNX	2019-05-06
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

Similar Registrations

Registration Number	Establishment Name	Location
3021915828	NICo-Lab B.V.	Amsterdam Noord-Holland, NL
3017604664	AVICENNA.AI	La Ciotat Bouches-du-Rhone, FR
3016727312	HEURON CO., LTD.	Seoul, KR
3023702863	Harrison-AI Medical Pty Ltd	Sydney New South Wales, AU
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014678441. Last updated year: 2026. Please use registration number 3014678441 when referencing this establishment in official correspondence.