K250959
- 510(k) number
- K250959
- Device name
- BioticsAI
- Applicant
- Bioticsai, Inc. CA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-12-22
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250959.pdf
Official FDA record: K250959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.