510(k) K960839

FILM SCANNER 300 by Cannon U.S.A., Inc. — Product Code LMA

K960839 is an FDA 510(k) premarket notification submitted by Cannon U.S.A., Inc. for the device "FILM SCANNER 300". The FDA issued a decision of Substantially Equivalent on December 18, 1996. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Cannon U.S.A., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1996
Date Received
February 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitizer, Image, Radiological
Device Class
Class II
Regulation Number
892.2030
Review Panel
RA
Submission Type