K233579
- 510(k) number
- K233579
- Device name
- SC1 Handheld Ultrasound Imaging system (Model: SC1)
- Applicant
- Fcu Co., Ltd. KR
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2024-06-26
- Date received
- 2023-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233579.pdf
Official FDA record: K233579
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.