K241949
- 510(k) number
- K241949
- Device name
- Digital Color Doppler Ultrasound System (P60 Series)
- Applicant
- Sonoscape Medical Corp. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-01-17
- Date received
- 2024-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241949.pdf
Official FDA record: K241949
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.