Radiology · 510(k) · 2026
Annalise Enterprise
Harrison-AI Medical Pty, Ltd.. Cleared by FDA on 3 March 2026 under submission K253818, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K253818
- Device. Annalise EnterpriseDEVICE
- Company. Harrison-AI Medical Pty, Ltd. (AU)COMPANY
- Decision. 3 March 2026, 510(k), substantially equivalent (traditional review); received 28 November 2025DECISION
- 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 (26 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.
Intended context Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings: • acute infarct* *See Additional Information, below. The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage. The device is not intended to direct attention to specific portions of an image and only provides notification for suspected findings. Its results are not intended: • to be used on a standalone basis for clinical decision making • to rule out specific findings, or otherwise preclude clinical assessment of non-contrast computed tomography brain Intended modality Annalise Enterprise identifies suspected findings in non-contrast brain CT studies.
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
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, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
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