Class Class II
BriefCase (K230020)
Description
BriefCase by Aidoc Medical , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230020
Clearance Date2023-02-01
Clearance TypeSpecial
Product CodeQFM
Regulation Number892.2080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230020
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 (K230020) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical , Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243548 | BriefCase-Triage | Aidoc Medical , Ltd. | 2024 |
Trace the full predicate network for K230020
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.