Class Class II
SuperSonic HepaVu (K242223)
Description
SuperSonic HepaVu by Supersonic Imagine, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242223
Clearance Date2024-09-20
Clearance TypeSpecial
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242223
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. SuperSonic HepaVu (K242223) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SU... | Supersonic Imagine | 2022 |
Trace the full predicate network for K242223
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.