Clearance Summary
AQUILA 320 D / AQUILA 320 S received FDA 510(k) clearance under submission number K201340, sponsored by Vmi Tecnologias Ltda. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-06-19.
- Submission: K201340
- Applicant / Sponsor: Vmi Tecnologias Ltda
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2020-06-19
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.