510(k) · Cleared
ClearedRapid Aneurysm Triage and Notification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ischemaview, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Jul 27, 2023 as substantially equivalent to K213319 (Viz. Ai, Inc., 2022) after a 198-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Jul 27, 2023
- Review
- 198 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 4 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 3 generations backK192901 HealthVCFZebra Medical Vision, Ltd. · 2020
- 2 generations backK193271 uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd. · 2021
- 1 generation backK213319 Viz ANEURYSM, Viz ANXViz. Ai, Inc. · 2022
- This deviceK230074 Rapid Aneurysm Triage and NotificationIschemaview, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −4 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −3 | K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020 | — |
| −2 | K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021 | — |
| −1 | K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022 | — |
| 0 (this device) | K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213319 | Viz ANEURYSM, Viz ANXSummary page 5…ces: The iSchemaView Rapid ANRTN device is claimed to be substantially equivalent to the following legally marketed predicate devices: Viz.AI’s Aneurysm Software (K213319) Device Description: Rapid ANRTN software device is a radiological computer-assisted image processing software device. The Rapid… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K213319.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (562 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230074: Rapid Aneurysm Triage and Notification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230074
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026