BriefCase

K222692

Aidoc Medical, Ltd. · cleared 2022-12-05 · product code QFM · 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 chest and abdominal CT images.”
Algorithmartificial intelligence, deep-learning algorithms
source quote (p.3)
“BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation.”
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=318 cases · 5 site(s)

endpoints: area under the curve (AUC); BriefCase time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (8 observations)

sensitivity95.11CI 90.92%-97.74%
source quote (p.8)
“Sensitivity was 95.11% (95% CI: 90.92%, 97.74%)”
specificity93.28CI 87.63%-96.88%
source quote (p.8)
“Specificity was 93.28% (95% CI: 87.63%, 96.88%).”
aurocas written: “auc”97.6CI 96.1%-99.1%
source quote (p.8)
“AUC was 97.6% (95% CI: 96.1%, 99.1%)”
npvas written: “NPV”99.5CI 99.1%-99.8%
source quote (p.8)
“NPV was 99.5% (95% CI: 99.1%-99.8%)”
ppvas written: “PPV”55.2CI 39.6%-69.8%
source quote (p.8)
“PPV was 55.2% (95% CI: 39.6%- 69.8%).”
ppvas written: “PLR”14.1606CI 7.528-26.637
source quote (p.8)
“PLR was 14.1606 (95% CI: 7.528-26.637)”
npvas written: “NLR”0.0524CI 0.028-0.099
source quote (p.8)
“NLR was 0.0524 (95% CI: 0.028- 0.099).”
time_to_resultas written: “BriefCase Time-to-notification”117.2CI 98.64-135.85
source quote (p.8)
“The BriefCase mean time-to-notification for Vertebral Compression Fractures was 117.2 seconds (95% CI: 98.64-135.85).”

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
16
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 10 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/K222692