BriefCase
K221330Aidoc Medical, Ltd. · cleared 2022-11-18 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“BriefCase is a radiological computer-assisted triage and notification software device.”
source quote (p.5)
“Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with DICOM 3.0 compliant x-ray scanners, PACS, and radiology workstations.”
Validation studies (1)
Retrospective clinical
n=921 cases · 5 site(s)
endpoints: sensitivity; specificity; time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)
Reported performance (7 observations)
source quote (p.9)
“Sensitivity was 86.81% (95% CI: 81.02%-91.36%)”
source quote (p.9)
“Specificity was 92.02% (95% CI: 89.20%-93.87%).”
source quote (p.9)
“NPV was 98.43% (95% CI: 97.74% - 98.92%), 96.54% (95% CI: 95.05% 97.59%) and 94.21% (95% CI: 91.81% 95.94%) at 10%, 20% and 30% positive prevalence.”
source quote (p.9)
“PPV was 54.71% (95% CI: 48.45% 60.83%), 73.11% (95% CI: 67.89%- 77.75%) and 82.33% (95% CI: 78.38%- 85.70%) at 10%, 20% and 30% positive prevalence.”
source quote (p.9)
“PLR was 10.874 (95% CI: 8.458-13.979)”
source quote (p.9)
“NLR was 0.143 (95% CI: 0.099- 0.208).”
source quote (p.9)
“BriefCase Time-to-notification 4.93 182 4.64 5.22 4.13 0.76”
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 11 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).