510(k) K945039

MCI OPTONIX CASSETTE OKAMOTO CASSETE by Mci Optonix, Inc. — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
October 14, 1994
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