K261272
- 510(k) number
- K261272
- Device name
- ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system
- Applicant
- Esonic Technology (Wuhan) Co., Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-07-23
- Date received
- 2026-04-17
- 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: K261272.pdf
Official FDA record: K261272
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.