510(k) K101036

SHIMADZU COLLIMATOR R-20J by Shimadzu Corp. — Product Code IZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2010
Date Received
April 14, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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