Class Class II
Sonosite LX Ultrasound System (K251830)
Description
Sonosite LX Ultrasound System by Fujifilm Sonosite, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251830
Clearance Date2025-07-10
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251830
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. Sonosite LX Ultrasound System (K251830) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; Fre... | Abbott Diabetes Care, Inc. | 2024 |
| K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2023 |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2019 |
Trace the full predicate network for K251830
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.