BriefCase

K214043

Aidoc Medical, Ltd. · cleared 2022-03-14 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“BriefCase is a radiological computer-assisted triage and notification software device.”
Algorithmartificial intelligence deep-learning algorithms
source quote (p.5)
“Both devices are artificial intelligence deep-learning algorithms incorporating software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations.”
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=619 cases · 5 site(s)

endpoints: software's performance in identifying Pneumothorax in chest X-ray exams; AUC; Sensitivity; Specificity; time-to-notification (TTN); NPV; PPV; PLR; NLR

Reported performance (8 observations)

sensitivity94.2CI 89.9%-97.8%
source quote (p.9)
“Sensitivity was 94.2% (95% CI: 89.9%, 97.8%)”
specificity90.8CI 88.1%-93.1%
source quote (p.9)
“Specificity was 90.8% (95% CI: 88.1%, 93.1%).”
aurocas written: “auc”0.969CI 0.954, 0.985
source quote (p.9)
“AUC was 0.969 (95% CI: 0.954, 0.985)”
time_to_resultas written: “Time-to-notification (BriefCase)”13.1CI 10.6 -15.7
source quote (p.9)
“The BriefCase time-to-notification for Pneumothorax was 13.1 seconds (95% CI: 10.6 -15.7 ; Median 11.8, IQR 15.8)”
npvas written: “NPV”99.3CI 98.6%-99.6%
source quote (p.9)
“NPV was 99.3% (95% CI: 98.6%-99.6%)”
ppvas written: “PPV”53.3CI 46.2%-60.3%
source quote (p.9)
“PPV was 53.3 % (95% CI: 46.2%-60.3%).”
ppvas written: “PLR”10.28CI 7.73%-13.67%
source quote (p.9)
“PLR was 10.28% (95% CI: 7.73%-13.67%)”
npvas written: “NLR”0.06CI 0.03%-0.12%
source quote (p.9)
“NLR was 0.06 % (95% CI: 0.03%-0.12%).”

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
25
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 19 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/K214043