K243628
- 510(k) number
- K243628
- Device name
- Vivid T9/Vivid T8
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics WI · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-02-11
- Date received
- 2024-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243628.pdf
Official FDA record: K243628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.