Clearance Summary
Wireless Digital Flat Panel Detector received FDA 510(k) clearance under submission number K161730, sponsored by Iray Technology (Shanghai) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-12-08.
- Submission: K161730
- Applicant / Sponsor: Iray Technology (Shanghai) , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2016-12-08
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.