Clearance Summary
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems received FDA 510(k) clearance under submission number K191007, sponsored by Supersonic Imagine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-10-25.
- Submission: K191007
- Applicant / Sponsor: Supersonic Imagine
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2019-10-25
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.