K241554
- 510(k) number
- K241554
- Device name
- Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
- Applicant
- Telefield Medical Imaging (Shenzhen) Limited CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-10-24
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241554.pdf
Official FDA record: K241554
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.