Cleared Traditional

Annalise Enterprise

K253818 · Harrison-AI Medical Pty, Ltd. · Radiology

Mar 2026

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K253818 is an FDA 510(k) clearance for the Annalise Enterprise, a Radiological Computer-assisted Triage And Notification Software (Class II — Special Controls, product code QAS), submitted by Harrison-AI Medical Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on March 3, 2026, 95 days after receiving the submission on November 28, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number	K253818 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2025
Decision Date	March 03, 2026
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QAS — Radiological Computer-assisted Triage And Notification Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2080
Definition	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 .