# K213319: Viz ANEURYSM, Viz ANX

- Pathway: 510(k) (Traditional)
- Applicant: Viz. Ai, Inc.
- Decided: Feb 18, 2022 after 137 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170073 (2018). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193271: uAI EasyTriage-Rib, Shanghai United Imaging Intelligence Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K230074: Rapid Aneurysm Triage and Notification (2023), 0 descendants of its own
- K223443: Viz AAA (2023), 0 descendants of its own

## Indications for use
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care. Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision. Viz ANEURYSM is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. Viz ANEURYSM is limited to detecting aneurysms at least 4mm in diameter.

Source page: https://510kreport.com/device/K213319
Methodology: https://510kreport.com/methodology