Cleared Special

Annalise Enterprise

K250831 · Annalise-Ai · Radiology
Apr 2025
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K250831 is an FDA 510(k) clearance for the Annalise Enterprise, a Radiological Computer-assisted Prioritization Software For Lesions (Class II — Special Controls, product code QFM), submitted by Annalise-Ai (Sydney, AU). The FDA issued a Cleared decision on April 23, 2025, 35 days after receiving the submission on March 19, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number K250831 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2025
Decision Date April 23, 2025
Days to Decision 35 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QFM — Radiological Computer-assisted Prioritization Software For Lesions
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2080
Definition 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.