Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (K243226)
Description
Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) by Leltek, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243226
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. Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (K243226) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging Syst... | Leltek, Inc. | 2024 |
| K231301 | Vscan Air | GE Medical Systems Ultrasound and P... | 2023 |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU... | Shimadzu Medical Systems | 2005 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and P... | 2025 |
Trace the full predicate network for K243226
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.