Cleared Traditional

Vscan Air

K250087 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
May 2025
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K250087 is an FDA 510(k) clearance for the Vscan Air, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on May 1, 2025, 107 days after receiving the submission on January 14, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K250087 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2025
Decision Date May 01, 2025
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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