510(k) K071409
K071409 is an FDA 510(k) premarket notification submitted by Imaging Dynamics Company , Ltd. for the device "X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 8, 2007. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Imaging Dynamics Company , Ltd. has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 2007
- Date Received
- May 21, 2007
- Clearance Type
- Special
- 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)