510(k) K202035

Vscan Air by GE Medical Systems Ultrasound And Primary Care Diagnostics — Product Code ITX

K202035 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound And Primary Care Diagnostics for the device "Vscan Air". The FDA issued a decision of Substantially Equivalent on Nov 20, 2020. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. GE Medical Systems Ultrasound And Primary Care Diagnostics has 82 other 510(k) clearances on record.