K250026
- 510(k) number
- K250026
- Device name
- Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
- Applicant
- Wuxi Hisky Medical Technologies Co., Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-10-01
- Date received
- 2025-01-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250026.pdf
Official FDA record: K250026
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.