K261288
- 510(k) number
- K261288
- Device name
- Handheld Ultrasound Scanner
- Applicant
- IMGFAX CO., LTD. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-07-30
- Date received
- 2026-04-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K261288.pdf
Official FDA record: K261288
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.