Clearance Summary
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM received FDA 510(k) clearance under submission number K090062, sponsored by Direct Digital Imaging Technology (Beijing), Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-05-18.
- Submission: K090062
- Applicant / Sponsor: Direct Digital Imaging Technology (Beijing), Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2009-05-18
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.