K250791
- 510(k) number
- K250791
- Device name
- ASUS Ultrasound Imaging System (LU800 series)
- Applicant
- Asustek Computer, Inc. TW
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-12-04
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250791.pdf
Official FDA record: K250791
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.