BriefCase-Triage

K232751

Aidoc Medical, Ltd. · cleared 2023-10-30 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“BriefCase-Triage is a radiological computer-aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and older.”
Algorithmartificial intelligence, deep learning algorithm
source quote (p.4)
“BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. As is customary in the field of machine learning, deep learning algorithm development consisted of training on manually labeled ("tagged") images.”
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)

Retrospective clinical

n=328 patients · 6 site(s)

endpoints: sensitivity; specificity; BriefCase-Triage time-to-notification compared to the predicate device; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (8 observations)

sensitivity89.2CI 95% CI: 82.5%, 93.9%
source quote (p.10)
“Sensitivity was 89.2% (95% CI: 82.5%, 93.9%)”
specificity94.5CI 95% CI: 90.3%, 97.2%
source quote (p.10)
“specificity was 94.5% (95% CI: 90.3%, 97.2%).”
npvas written: “NPV”99.2CI 95% CI: 98.7%- 99.5%
source quote (p.11)
“NPV was 99.2% (95% CI: 98.7%- 99.5%)”
ppvas written: “PPV”52.9CI 95% CI: 38.6%- 66.6%
source quote (p.11)
“PPV was 52.9% (95% CI: 38.6%- 66.6%).”
ppvas written: “PLR”16.1CI 95% CI: 9.1-28.7
source quote (p.11)
“PLR was 16.1 (95% CI: 9.1-28.7”
npvas written: “NLR”0.1CI 95% CI: 0.1-0.2
source quote (p.11)
“NLR was 0.1 (95% CI: 0.1-0.2).”
sensitivityas written: “AOP1 Sensitivity”96.9CI 95% CI: 92.3%-99.2%
source quote (p.12)
“AOP1: Sensitivity was 96.9% (95% CI: 92.3%-99.2%)”
specificityas written: “AOP1 Specificity”85.9CI 95% CI: 80.3%-90.4%
source quote (p.12)
“AOP1: Sensitivity was 96.9% (95% CI: 92.3%-99.2%) and specificity was 85.9% (95% CI: 80.3%-90.4%).”

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
9
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253578 (decision 2026-02-26) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253578

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251195 (decision 2026-01-27) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251195

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252970 (decision 2026-01-07) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-triage CT Body") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252970

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253265 (decision 2025-11-06) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253265

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251406 (decision 2025-05-30) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251406

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250248 (decision 2025-02-14) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250248

  • …and 3 more.

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/K232751