Class Class II
BriefCase-Triage (K251406)
Description
BriefCase-Triage by Aidoc Medical , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251406
Clearance Date2025-05-30
Clearance TypeSpecial
Product CodeQAS
Regulation Number892.2080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251406
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BriefCase-Triage (K251406) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243548 | BriefCase-Triage | Aidoc Medical , Ltd. | 2024 |
| K222329 | BriefCase | Aidoc Medical , Ltd. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pe... | Aidoc Medical , Ltd. | 2026 |
Trace the full predicate network for K251406
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.