BriefCase
K222692Aidoc Medical, Ltd. · cleared 2022-12-05 · product code QFM · 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)
“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. Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with PACS and radiology workstations.”
Validation studies (1)
Retrospective clinical
n=318 cases · 5 site(s)
endpoints: pre-specified standalone performance goal (PG) of area under the curve (AUC) > 0.95 for the study level receiver operating characteristic (ROC) curve; 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 (8 observations)
source quote (p.8)
“Sensitivity was 95.11% (95% CI: 90.92%, 97.74%)”
source quote (p.8)
“Specificity was 93.28% (95% CI: 87.63%, 96.88%)”
source quote (p.8)
“AUC was 97.6% (95% CI: 96.1%, 99.1%)”
source quote (p.8)
“NPV was 99.5% (95% CI: 99.1%-99.8%)”
source quote (p.8)
“PPV was 55.2% (95% CI: 39.6%- 69.8%).”
source quote (p.8)
“PLR was 14.1606 (95% CI: 7.528-26.637)”
source quote (p.8)
“NLR was 0.0524 (95% CI: 0.028- 0.099).”
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
- 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). 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).