LMB · Class I · 21 CFR 892.2010

FDA Product Code LMB: Device, Digital Image Storage, Radiological

Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.

Leading manufacturers include Eastman Kodak Company, Sectra-Imtec AB and O Tech, Inc..

55
Total
55
Cleared
120d
Avg days
1983
Since
55 devices
25–48 of 55
Cleared Sep 18, 1995
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
K952888
Olympus America, Inc.
Radiology · 87d
Cleared Feb 17, 1995
NICOM DIGITAL IMAGE MANAGER
K945654
Camtronics, Ltd.
Radiology · 92d
Cleared Apr 07, 1994
DIGITAL DISK RECORDER
K933115
Eigen
Radiology · 286d
Cleared Mar 02, 1992
KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
K914728
Eastman Kodak Company
Radiology · 133d
Cleared Dec 18, 1991
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
K905488
Ausonics Pty , Ltd.
Radiology · 376d
Cleared Apr 10, 1990
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
K901118
Adac Laboratories
Radiology · 29d
Cleared Jun 15, 1989
KODAK EKTASCAN IMAGE MANAGER
K891690
Eastman Kodak Company
Radiology · 85d
Cleared May 11, 1989
PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
K885327
Philips Medical Systems North America, Inc.
Radiology · 134d
Cleared Oct 30, 1987
KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET
K873048
Eastman Kodak Company
Radiology · 87d
Cleared Oct 27, 1986
ERS SYSTEM
K863286
General Electric Co.
Radiology · 63d