510(k) K060079
K060079 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 8, 2006. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2006
- Date Received
- January 10, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type