# K230074: Rapid Aneurysm Triage and Notification

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Jul 27, 2023 after 198 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 5.

## Indications for use
Rapid Aneurysm Triage and Notification (ANRTN) 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 saccular aneurysms during routine patient care. Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular 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 PACS, email and mobile application. When viewed the images are for informational purposes only and not for diagnostic use. The results of Rapid ANRTN, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of saccular aneurysm cases. Radiologists who read the original medical images are responsible for the diagnostic decision. Rapid ANRTN 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. Rapid ANRT is limited to detecting saccular aneurysms at least 4mm in diameter in adults. Inclusion Criteria: The module shall detect unruptured saccular brain aneurysms greater than or equal to 4 mm in size within the following anatomical region: Internal Carotid Artery (ICA): ophthalmic segment to ICA terminus Middle Cerebral Artery (MCA): M1 segment through M1/M2 bifurcation Anterior Cerebral Artery (ACA): Al and A2 segments Anterior Communicating Artery (ACOM) Posterior Communicating Artery (PCOM) Posterior Cerebral Artery (PCA): P1 segment Vertebral Artery (VA): intracranial portion of the VA through the vertebrobasilar (VB) junction Basilar Artery (BA) Contraindications/Exclusions/Cautions: The module shall process only CTA datasets with a patient position of “headfirst supine’. The module shall process only a series within CTA datasets comprised only of axial slices. The module shall process only CTA datasets with Z FOV (cranio-caudal transverse anatomical coverage) greater than or equal to 90 mm The module shall process only CTA datasets with in-plane pixel spacing (X & Y resolution): 0.2 — 1.0 mm The module shall process only CTA datasets with in-plane X FOV: 160-400mm. The module shall process only CTA datasets with in-plane Y FOV: 160-400 mm The module shall process only CTA datasets with Z slice spacing of 0.2 — 1.25 mm The module shall process only CTA datasets with data acquired at x-ray tube voltage 80kVp-140kVp, as reported in the input data DICOM header The module shall process only CTA datasets consisting of input slices of continuous order without gaps. The module shall process only CTA datasets where the images belong to a single series (i.e., identical SeriesInstanceUID DICOM tag value for all images). The module shall not process CTA datasets where the DICOM tags “ImagePositionPatient” (IPP), “ImageOrientationPatient” (IOP), or “PixelSpacing™ are missing The module shall only process a single series per study, being the largest available that passes the above requirements. The module shall accept input files within a parent folder named by a unique identifier for the case. The module shall accept axial-oblique CTA datasets with an oblique plane of <35 degrees. Cases with significant motion and/or imaging artifacts.

Source page: https://510kreport.com/device/K230074
Methodology: https://510kreport.com/methodology