K252237
- 510(k) number
- K252237
- Device name
- EdgeFlow UW20
- Applicant
- Edgecare, Inc. KR
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2026-04-17
- Date received
- 2025-07-17
- 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: K252237.pdf
Official FDA record: K252237
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.