# K250831: Annalise Enterprise

- Pathway: 510(k) (Special)
- Applicant: Annalise-Ai
- Decided: Apr 23, 2025 after 35 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: 6 generations back to DEN170073 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222179: Annalise Enterprise CXR Triage Trauma, Annalise-Ai Pty, Ltd. (2023) Summary page 6.

## Indications for use
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: * pleural effusion* [1] * pneumoperitoneum* [2] * pneumothorax * tension pneumothorax * vertebral compression fracture* [3] *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 chest X-ray studies Intended modality: Annalise Enterprise identifies suspected findings in digitized (CR) or digital (DX) chest X-ray studies. Intended user: The device is intended to be used by trained clinicians who are qualified to interpret chest X-ray 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 following additional information relates to the findings listed above: [1] Pleural effusion » specificity may be reduced in the presence of scarring and/or pleural thickening « standalone performance evaluation was performed on a dataset that included supine and erect positioning « use of this device with prone positioning may result in differences in performance [2] Pneumoperitoneum « standalone performance evaluation was performed on a dataset that included supine and erect positioning where most cases were of unilateral right-sided and bilateral pneumoperitoneum » use of this device with prone positioning and for unilateral left-sided pneumoperitoneum may result in differences in performance [3] Vertebral compression fracture * intended for prioritization or triage of worklists of Bone Health and Fracture Liaison Service program clinicians « standalone performance evaluation was performed on a dataset that included only erect positioning « use of this device with supine positioning may result in differences in performance

Source page: https://510kreport.com/device/K250831
Methodology: https://510kreport.com/methodology