# K253818: Annalise Enterprise

- Pathway: 510(k) (Traditional)
- Applicant: Harrison-AI Medical Pty, Ltd.
- Decided: Mar 3, 2026 after 95 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- 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: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222884: Rapid NCCT Stroke, Ischemaview, Inc. (2023) Summary page 6.

## Indications for use
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. Intended user The device is intended to be used by trained clinicians who are qualified to interpret CTB studies as part of their scope of practice. Intended patient population The intended population is patients who are 22 years or older. Additional information The device includes acute infarct of the cerebral hemispheres or cerebellum, also including early signs of acute middle cerebral artery (MCA) infarct such as insular ribbon sign and disappearing basal ganglia sign. The infarct must be a completed infarct (i.e. include an ischemic core of ≥5mL). The device also includes hyperdense artery in the anterior circulation but does not include lacunar infarcts, brainstem infarcts or venous infarcts. The radiological device definition of acute infarct includes the following territories and regions: • anterior cerebral artery (ACA) • middle cerebral artery (MCA) • posterior cerebral artery (PCA) • cerebellum • basilar artery occlusions • watershed regions Specificity may be reduced in the presence of infarcts of <5mL. Caution: All patients should get adequate care for their symptoms, including advanced imaging (e.g., CTA, CTP, MRI, etc.) and/or other appropriate care per standard clinical practice, irrespective of the device output. The device is not intended to be a rule-out device and for cases that have been processed by the device, an absence of a notification for suspected acute infarct should not be viewed as indicating that acute infarct is excluded. Limitations: The device does not replace the need for advanced imaging in the stroke workup. It provides workflow prioritization and notification only.

Source page: https://510kreport.com/device/K253818
Methodology: https://510kreport.com/methodology