510(k) K951807

KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER by Kodak Health Imaging Systems, Inc. — Product Code LMC

K951807 is an FDA 510(k) premarket notification submitted by Kodak Health Imaging Systems, Inc. for the device "KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER". The FDA issued a decision of Substantially Equivalent on September 13, 1995. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Kodak Health Imaging Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1995
Date Received
April 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type