510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213941Substantially Equivalent

Annalise Enterprise CXR Triage Pneumothorax

Annalise-Ai Pty, Ltd., Sydney, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213941 is the FDA 510(k) clearance record for Annalise Enterprise CXR Triage Pneumothorax, a class II device, cleared for Annalise-Ai on under FDA product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions). FDA's definition for product code QFM reads: "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...". FDA records list 8 510(k) clearances for Annalise-Ai, from to . As of , FDA records show no recalls naming K213941.

Clearance record

Decision date
Received
(70 days to decision)
Product code
QFM Radiological Computer-Assisted Prioritization Software For Lesions
Regulation
21 CFR 892.2080
Device class
Class II
Review panel
Radiology
Applicant
Annalise-Ai Level 21, 60 Margaret St., Sydney, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFM

Trailing 12 months
3 clearances under product code QFM in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QFM, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260