K231965
- 510(k) number
- K231965
- Device name
- Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics WI · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-10-30
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K231965.pdf
Official FDA record: K231965
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.