510(k) K072780

MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR by Ralco S.R.L. — Product Code IZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2007
Date Received
September 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Automatic, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type