Clearance Summary
DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 received FDA 510(k) clearance under submission number K093816, sponsored by Medien International Co, 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 2010-10-05.
- Submission: K093816
- Applicant / Sponsor: Medien International Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2010-10-05
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.