BriefCase

K213886

Aidoc Medical, Ltd. · cleared 2022-04-26 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and consists of a standard off-the-shelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application.”

Algorithmdeep learning AI algorithms

source quote (p.8)

“Both devices are software packages with identical technological characteristics and principles of operation, both incorporating the same deep learning AI algorithms that process images, and software to send notifications and unannotated compressed preview images to the user's desktop.”

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=159 cases · 3 site(s)

endpoints: evaluate the software's performance in identifying Contrast-enhanced chest CTs (not dedicated CTPA protocol, acquired through Philips and Toshiba scanners), containing Incidental Pulmonary Embolism

Reported performance (5 observations)

sensitivity0.897CI 95% CI: 80.8%, 95.5%

source quote (p.7)

“Specifically, sensitivity was 89.7 % (95% CI: 80.8%, 95.5%) and specificity was 90.1% (95% CI: 81.5%, 95.6%).”

specificity0.901CI 95% CI: 81.5%, 95.6%

source quote (p.7)

“Specifically, sensitivity was 89.7 % (95% CI: 80.8%, 95.5%) and specificity was 90.1% (95% CI: 81.5%, 95.6%).”

npvas written: “Negative Predictive Value”0.997CI 99.4%, 99.8%

source quote (p.8)

“Negative Predictive Value 99.7% 99.4% 99.8%”

ppvas written: “Positive Predictive Value”0.195CI 11.1%, 32.0%

source quote (p.8)

“Positive Predictive Value 19.5% 11.1% 32.0%”

time_to_resultas written: “Time to notification”4.7

source quote (p.8)

“the contribution of the BriefCase software is in reducing the time span until an exam is opened to several minutes for cases with suspect findings (4.7 min BriefCase time to notification compared to 223.3 min time-to-exam-open in the standard of care).”

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 17 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).