Clearance Summary
XPLORER 1600 PLUS received FDA 510(k) clearance under submission number K062586, 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 2006-09-29.
- Submission: K062586
- Applicant / Sponsor: Imaging Dynamics Company , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2006-09-29
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.