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.”
Algorithmconvolutional 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
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

n=366 cases · 5 site(s)

endpoints: standalone model performance; triage effectiveness; sensitivity; specificity

standards: FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, May 11, 2005.

Reported performance (2 observations)

sensitivity94.7CI 93.1, 100.0
source quote (p.10)
“94.7 (93.1, 100.0)”
specificity95CI 90.0, 99.0
source quote (p.10)
“95.0 (90.0, 99.0)”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K231094