510(k) Report

Devices descending from K241161

3 later devices reach Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+1K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+2K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—