FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (K223902)
Description
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) by Echosens, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223902
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. FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (K223902) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212035 | FibroScan 230 | Echosens | 2021 |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compa... | Echosens | 2021 |
Trace the full predicate network for K223902
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.