510(k) K093816
K093816 is an FDA 510(k) premarket notification submitted by Medien International Co, Ltd. for the device "DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600". The FDA issued a decision of Substantially Equivalent on Oct 5, 2010. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Medien International Co, Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2010
- Date Received
- Dec 11, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)