Clearance Summary
PORTABLE X-RAY SYSTEM, MODEL HAND-RAY received FDA 510(k) clearance under submission number K092772, sponsored by Hanjin Digi-X Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-01-06.
- Submission: K092772
- Applicant / Sponsor: Hanjin Digi-X Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2010-01-06
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.