K243226
- 510(k) number
- K243226
- Device name
- Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
- Applicant
- Leltek, Inc. TW
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-05-08
- Date received
- 2024-10-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243226.pdf
Official FDA record: K243226
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.