510(k) K111508

TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 by Hologic, Inc. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2011
Date Received
June 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type