Cleared Special

K250831 - Annalise Enterprise (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250831 · Annalise-Ai · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
35d
Days
Class 2
Risk

K250831 is an FDA 510(k) clearance for the Annalise Enterprise. Classified as Radiological Computer-assisted Prioritization Software For Lesions (product code QFM), Class II - Special Controls.

Submitted by Annalise-Ai (Sydney, AU). The FDA issued a Cleared decision on April 23, 2025 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2080 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Annalise-Ai devices

Submission Details

510(k) Number K250831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QFM Radiological Computer-assisted Prioritization Software For Lesions
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QFM Radiological Computer-assisted Prioritization Software For Lesions

All 38
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