510(k) K073124

COLLIMARE COLLIMATOR FAMILY by Collimare, LLC — Product Code IZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2007
Date Received
November 6, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

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