K232459
- 510(k) number
- K232459
- Device name
- Velacur
- Applicant
- Sonic Incytes CA
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2023-09-12
- Date received
- 2023-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232459.pdf
Official FDA record: K232459
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.