K260748
- 510(k) number
- K260748
- Device name
- ES-Series
- Applicant
- E-Scopics FR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-06-09
- Date received
- 2026-03-06
- 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: K260748.pdf
Official FDA record: K260748
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.