Radiology · 510(k) · 2023
Brainomix 360 Triage LVO
Brainomix Limited. Cleared by FDA on 28 September 2023 under submission K231837, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K231837
- Device. Brainomix 360 Triage LVODEVICE
- Company. Brainomix Limited (GB)COMPANY
- Decision. 28 September 2023, 510(k), substantially equivalent (traditional review); received 22 June 2023DECISION
- Panel. RadiologyPANEL
- Product code. QAS, Radiological Computer-Assisted Triage And Notification SoftwareCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Brainomix Triage LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. Brainomix Triage LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting, and sends notifications to a neurovascular specialist that a suspected large vessel occlusion (LVO) has been identified and recommends review of those images. Images can be previewed through a mobile application or via email. Brainomix Triage LVO is intended to analyze terminal ICA and MCA-M1 vessels for LVOs. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notific ation. Notified clinicians are responsible for viewing noncompressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care -related decisions or requests. Brainomix Triage LVO is limited to analysis of imaging data and should not be used in-lieu of […]
The product code's definition, from FDA's classification record. Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QAS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QAS, in Radiology, from Brainomix Limited, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.