K242223
- 510(k) number
- K242223
- Device name
- SuperSonic HepaVu
- Applicant
- Supersonic Imagine FR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-09-20
- Date received
- 2024-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242223.pdf
Official FDA record: K242223
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.