BriefCase

K221314

Aidoc Medical, Ltd. · cleared 2022-06-03 · 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 head CTA images in adults or transitional adolescents aged 18 and older.”

Algorithmartificial intelligence, deep-learning algorithms

source quote (p.5)

“Both devices are artificial intelligence, deep-learning algorithms incorporated software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations.”

Adaptive (vs locked)No

source quote (p.5)

“Both devices are intended to aid in triage and prioritization of radiological images and utilize the same design of deep learning algorithm trained on medical images.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=383 patients

endpoints: evaluate the software's performance in identifying head CTA images containing M1 Large Vessel Occlusion (M1-LVO)

Reported performance (5 observations)

sensitivity0.888CI 95% CI: 81.9%, 93.8%

source quote (p.7)

“Sensitivity was 88.8% (95% CI: 81.9%, 93.8%)”

specificity0.872CI 95% CI: 82.5%, 91.1%

source quote (p.7)

“and specificity was 87.2% (95% CI: 82.5%, 91.1%).”

npvas written: “NPV”0.995CI 95% CI: 99.3%-99.8%

source quote (p.8)

“NPV was 99.5% (95% CI: 99.3%-99.8%)”

ppvas written: “PPV”0.201CI 95% CI: 13.2%-24.2%

source quote (p.8)

“and PPV was 20.1% (95% CI: 13.2%-24.2%).”

time_to_resultas written: “mean time-to-notification for M1-LVO”3.8CI 95% CI: 3.6-4.0

source quote (p.8)

“The BriefCase mean time-to-notification for M1-LVO was 3.8 minutes (95% CI: 3.6-4.0).”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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 15 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).