K230511
- 510(k) number
- K230511
- Device name
- K3900 Ultrasound Imaging System
- Applicant
- Maui Imaging WA · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2023-10-25
- Date received
- 2023-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230511.pdf
Official FDA record: K230511
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.