510(k) K972163

IMATION SE-196 LASER IMAGER by Imation Corp. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
June 9, 1997
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