K243298
- 510(k) number
- K243298
- Device name
- Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
- Applicant
- Carbon (Shenzhen) Medical Device Co., Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-04-03
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243298.pdf
Official FDA record: K243298
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.