510(k) K090469

CARESTREAM DRYVIEW 5850 LASER IMAGER by Carestream Health, Inc. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2009
Date Received
February 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type