BriefCase
K221240Aidoc Medical, Ltd. · cleared 2022-05-17 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The 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.”
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.”
Validation studies (1)
Retrospective clinical
n=220 cases · 5 site(s)
endpoints: sensitivity; specificity; BriefCase time-to-notification compared to the predicate device; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)
Reported performance (7 observations)
source quote (p.8)
“Sensitivity was 96.15% (95% CI: 90.44%, 98.94%)”
source quote (p.8)
“specificity was 94.83% (95% CI: 89.08%, 98.08%).”
source quote (p.8)
“NPV was 99.29% (95% CI: 98.16% - 99.73%)”
source quote (p.8)
“PPV was 76.64% (95% CI: 60.06% - 87.74%).”
source quote (p.8)
“PLR was 18.59 (95% CI: 8.52 - 40.56)”
source quote (p.8)
“NLR was 0.04 (95% CI: 0.02 - 0.11)”
source quote (p.8)
“BriefCase Time-to-notification (in seconds) Mean Estimate 33.5 95% Lower CL 30.9 95% Upper CL 36.1”
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
- 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 16 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).