Class Class II
Clarius AI (K222406)
Description
Clarius AI by Clarius Mobile Health Corp., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222406
Clearance Date2023-01-23
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222406
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. Clarius AI (K222406) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220497 | CoLumbo | Smart Soft Healthcare AD | 2022 |
| K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2020 |
| K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250226 | Clarius Median Nerve AI | Clarius Mobile Health Corp. | 2025 |
Trace the full predicate network for K222406
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.