K251728
- 510(k) number
- K251728
- Device name
- Velacur One (LI-1100)
- Applicant
- Sonic Incytes Medical Corp CA
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2025-06-26
- Date received
- 2025-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251728.pdf
Official FDA record: K251728
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.