510(k) K920031

KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE by Eastman Kodak Company — Product Code JAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1992
Date Received
January 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Film Marking, Radiographic
Device Class
Class I
Regulation Number
892.1640
Review Panel
RA
Submission Type