K251268
- 510(k) number
- K251268
- Device name
- Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-12-23
- Date received
- 2025-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251268.pdf
Official FDA record: K251268
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.