Clearance Summary
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D received FDA 510(k) clearance under submission number K083640, sponsored by Choong Wae Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-06-29.
- Submission: K083640
- Applicant / Sponsor: Choong Wae Medical Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2009-06-29
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.