Radiology · 510(k) · 2025
Annalise Enterprise
Annalise-AI. Cleared by FDA on 23 April 2025 under submission K250831, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K250831
- Device. Annalise EnterpriseDEVICE
- Company. Annalise-AI (AU)COMPANY
- Decision. 23 April 2025, 510(k), substantially equivalent (special review); received 19 March 2025DECISION
- Panel. RadiologyPANEL
- Product code. QFM, Radiological Computer-Assisted Prioritization Software For LesionsCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (13 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.
statement is as follows: 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 effusion1 • pneumoperitoneum2 • pneumothorax • tension pneumothorax • vertebral compression fracture3 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.
The product code's definition, from FDA's classification record. Radiological computer-assisted prioritization software for lesions 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 namedradiographs (X-ray)
- 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 QFM. 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 QFM, in Radiology, from Annalise-AI, or cleared in 2025. 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.