K232895
- 510(k) number
- K232895
- Device name
- B-Ultrasound Diagnostic System
- Applicant
- Contec Medical Systems Co.,Ltd CN
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2024-05-03
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K232895.pdf
Official FDA record: K232895
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.