# K223443: Viz AAA

- Pathway: 510(k) (Traditional)
- Applicant: Viz. Ai, Inc.
- Decided: Mar 17, 2023 after 123 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: 5 generations back to DEN170073 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213319: Viz ANEURYSM, Viz ANX, Viz. Ai, Inc. (2022) Summary page 4.

## Indications for use
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular or endovascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care. Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected abdominal aortic 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 AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular or endovascular specialists who read the original medical images are responsible for the diagnostic decision. Viz AAA 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 AAA is limited to detecting aneurysms at least 3 cm in diameter. Viz AAA is intended to identify infra-renal, fusiform abdominal aortic aneurysms.

Source page: https://510kreport.com/device/K223443
Methodology: https://510kreport.com/methodology