K250087
- 510(k) number
- K250087
- Device name
- Vscan Air
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics WI · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-05-01
- Date received
- 2025-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250087.pdf
Official FDA record: K250087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.