K230986
- 510(k) number
- K230986
- Device name
- Bladder Scanner
- Applicant
- Avantsonic Technology Co., Ltd. CN
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2023-12-29
- Date received
- 2023-04-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230986.pdf
Official FDA record: K230986
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.