510(k) K961768

KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) by Kodak Health Imaging Systems, Inc. — Product Code LMA

K961768 is an FDA 510(k) premarket notification submitted by Kodak Health Imaging Systems, Inc. for the device "KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)". The FDA issued a decision of Substantially Equivalent on August 22, 1996. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Kodak Health Imaging Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1996
Date Received
May 8, 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