510(k) K071408

X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR by Imaging Dynamics Company , Ltd. — Product Code KPR

K071408 is an FDA 510(k) premarket notification submitted by Imaging Dynamics Company , Ltd. for the device "X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR". The FDA issued a decision of Substantially Equivalent on Jun 13, 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 13, 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)