Class Class II
Sonio Suspect (K243614)
Description
Sonio Suspect by Sonio, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243614
Clearance Date2025-02-21
Clearance TypeTraditional
Product CodePOK
Regulation Number892.2060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243614
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. Sonio Suspect (K243614) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240406 | Sonio Detect | Sonio | 2024 |
| K212616 | Koios DS | Koios Medical, Inc. | 2021 |
Trace the full predicate network for K243614
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.