Clearance Summary
Aquarius 8600 1417TG and Aquarius 8600 1717TG received FDA 510(k) clearance under submission number K171169, sponsored by Imaging Dynamics Company , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-10-12.
- Submission: K171169
- Applicant / Sponsor: Imaging Dynamics Company , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2017-10-12
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.