Clearance Summary
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 received FDA 510(k) clearance under submission number K091090, sponsored by E-Woo Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-08-09.
- Submission: K091090
- Applicant / Sponsor: E-Woo Technology
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2010-08-09
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.