Viz Aneurysm, Viz Anx
FDA 510(k)Class II (US FDA 510(k))
by Viz.ai, Inc.
Identifiers
- 510(k) Number
- K213319 FDA 510(k)
- FDA Product Code
- QFM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2080 FDA 510(k)
- Regulation Number
- 892.2080 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Viz Aneurysm, Viz Anx is a radiological computer-assisted prioritization software for lesions, specifically designed for the analysis of CT images of the head to auto-detect suspected cerebral aneurysms. It assists hospital networks and trained radiologists by flagging and prioritizing studies with suspected aneurysms. The device is classified as a radiology software device.
The Viz Aneurysm, Viz Anx is supplied as a software device, and its use is intended for radiology applications. It is a non-invasive device, and its storage and use are subject to the manufacturer's instructions. The device has been granted FDA 510K authorization, and its regulation number is 892.2080. The device is classified as a class 2 device.
Frequently asked questions
What is the Viz Aneurysm software used for?
The Viz Aneurysm software is used for radiology applications, specifically to auto-detect suspected cerebral aneurysms in CT images of the head.
Is the Viz Aneurysm software invasive?
No, the Viz Aneurysm software is a non-invasive device, assisting hospital networks and trained radiologists by flagging and prioritizing studies with suspected aneurysms.
How is the Viz Aneurysm software supplied?
The Viz Aneurysm software is supplied as a software device, with its use and storage subject to the manufacturer's instructions.
What regulatory authorization has the Viz Aneurysm software received?
The Viz Aneurysm software has been granted FDA 510K authorization, with a regulation number of 892.2080, and is classified as a class 2 device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Viz ANEURYSM Review: Pricing, FDA Status & Alternatives | Physician AI ..., Viz ANEURYSM - Viz.ai, Viz ANEURYSM, Viz ANX | Viz.ai, Inc. radiology AI profile, Viz.ai Solutions for Cerebral Aneurysm and AAA Detection Evaluated in ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213319 | Class II | Active |
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Manufacturer
- Manufacturer
- Viz.ai, Inc.
- FDA Applicant
- Viz. Ai, Inc.
Sources (1)
- FDA 510(k) K213319 24 fields · synced Sep 21, 2026