510(k) K980722

TRIMAX RADIOGRAPHIC CASSETTE by Imation Corp. — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1998
Date Received
February 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type