Class Class II
Velacur (K223287)
Description
Velacur by Sonic Incytes, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223287
Clearance Date2023-04-20
Clearance TypeTraditional
Product CodeIYO
Regulation Number892.1560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223287
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. Velacur (K223287) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201597 | Liver Incytes, Model 1005 | Sonic Incytes | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232459 | Velacur | Sonic Incytes | 2023 |
Trace the full predicate network for K223287
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.