Annalise Enterprise CTB Triage-OH

K231094

Annalise-AI Pty Ltd · cleared 2023-08-15 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Annalise Enterprise CTB Triage – OH is a software workflow tool which uses an artificial intelligence (AI) algorithm to identify suspected findings on non-contrast brain CT studies in the medical care environment.”

AlgorithmAI algorithm – a convolutional neural network trained using deep-learning techniques

source quote (p.6)

“Radiological findings are identified by the device using an AI algorithm – a convolutional neural network trained using deep-learning techniques.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=366 cases · 5 site(s)

Bench

n=277 cases

Reported performance (3 observations)

sensitivity0.973CI 93.3,100.0

source quote (p.10)

“97.3 (93.3,100.0)”

specificity0.94CI 89.0,98.0

source quote (p.10)

“94.0 (89.0,98.0)”

time_to_resultas written: “triage turn-around time”81.6CI 80.3 – 82.9

source quote (p.10)

“The results demonstrated a triage turn-around time of 81.6 (95%CI: 80.3 – 82.9) seconds”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K231767 (decision 2023-09-22) from Annalise-AI Pty Ltd for a matching device line ("Annalise Enterprise CTB Triage Trauma") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231767
re_clearance
The FDA AI/ML device list shows a newer 510(k) K231384 (decision 2023-09-22) from Annalise-AI Pty Ltd. for a matching device line ("Annalise Enterprise CTB Triage Trauma") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231384

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).