K252328
- 510(k) number
- K252328
- Device name
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics WI · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-11-24
- Date received
- 2025-07-25
- 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: K252328.pdf
Official FDA record: K252328
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.