510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231384Substantially Equivalent

Annalise Enterprise CTB Triage Trauma

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

K231384 is the FDA 510(k) clearance record for Annalise Enterprise CTB Triage Trauma, a class II device, cleared for Annalise-Ai Pty , Ltd. on under FDA product code QAS (Radiological Computer-Assisted Triage And Notification Software). FDA's definition for product code QAS reads: "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...". FDA records list 8 510(k) clearances for Annalise-Ai Pty , Ltd., from to . As of , FDA records show no recalls naming K231384.

Clearance record

Decision date
Received
(133 days to decision)
Product code
QAS Radiological Computer-Assisted Triage And Notification Software
Regulation
21 CFR 892.2080
Device class
Class II
Review panel
Radiology
Applicant
Annalise-Ai Pty , Ltd. Level P, 24 Campbell St., Sydney, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAS

Trailing 12 months
13 clearances under product code QAS in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code QAS, trailing twelve months
MonthClearances
November 20253
December 20250
January 20262
February 20261
March 20262
April 20261
May 20261
June 20261
July 20261
August 20260
September 20261
October 20260