Annalise Enterprise

K253818

Harrison-AI Medical Pty, Ltd. · cleared 2026-03-03 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“Annalise Enterprise 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.7)
“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 addressedYes
source quote (p.22)
“FDA Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

Validation studies (3)

Retrospective clinical

n=977 cases · 5 site(s)

Retrospective clinical

n=1,050 cases · 5 site(s)

Bench

n=277 cases

endpoints: Triage turn-around time

Reported performance (3 observations)

sensitivity89.2CI 85.8,92.6
source quote (p.20)
“0.063800 Se: 89.2 (85.8,92.6)”
specificity93.1CI 91.1,95.0
source quote (p.20)
“0.100900 Sp: 93.1 (91.1,95.0)”
aurocas written: “auc”0.952CI 0.937, 0.965
source quote (p.19)
“AUC (95% CI) 0.952 (0.937, 0.965)”

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
0
drift signals on this device

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/K253818