BriefCase

K193298

Aidoc Medical, Ltd. · cleared 2020-06-19 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies.”
Algorithmartificial intelligence algorithm; deep learning AI algorithms
source quote (p.3)
“BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings.”
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=184 cases · 3 site(s)

endpoints: evaluate the software's performance in identifying abdominal CTs containing Intra-abdominal Free Gas; Briefcase's potential clinical benefit of worklist prioritization for true positive IFG cases was evaluated by comparing the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for IFG, in the study sites where the time-to-exam-open information was available.

Reported performance (8 observations)

sensitivity91CI 81.5%, 96.7%
source quote (p.7)
“Specifically, sensitivity was 91.0% (95% CI: 81.5%, 96.7%) and specificity was 88.9% (95% CI: 81.7%, 94.0%).”
specificity88.9CI 81.7%, 94.0%
source quote (p.7)
“Specifically, sensitivity was 91.0% (95% CI: 81.5%, 96.7%) and specificity was 88.9% (95% CI: 81.7%, 94.0%).”
time_to_resultas written: “Time-to-exam-open in the standard of care”94.1CI 49.9-138.2
source quote (p.8)
“Time-to-exam-open in the standard of care 22 94.1 49.9 138.2 50.1 79.9”
time_to_resultas written: “Time-to-notification of BriefCase IFG”4.4CI 3.7-5.0
source quote (p.8)
“Time-to-notification of BriefCase IFG 22 4.4 3.7 5.0 4.2 2.5”
npvas written: “Negative Predictive Value (varying prevalence)”stated without value
source quote (p.8)
“NPV and PPV are presented in Table 3 by a range of prevalence.”
ppvas written: “Positive Predictive Value (varying prevalence)”stated without value
source quote (p.8)
“NPV and PPV are presented in Table 3 by a range of prevalence.”
npvas written: “NLR”0.1CI 0.0-0.2
source quote (p.9)
“NLR 184 0.1 0.0 0.2”
ppvas written: “PLR”8.2CI 4.9-13.8
source quote (p.9)
“PLR 184 8.2 4.9 13.8”

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
29
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 23 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/K193298