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, Eigen and Camtronics, Ltd..

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 Sep 15, 1995
TOMTECP90
K950279
Tomtec Imaging Systems, Inc.
Radiology · 234d
Cleared May 30, 1995
INSTACINE
K942558
Fidelity Medical, Inc.
Radiology · 364d
Cleared May 30, 1995
STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER
K951141
Star Technologies, Inc.
Radiology · 78d
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 Apr 01, 1994
7500 DATA TOWER
K935498
E-Systems, Inc.
Radiology · 136d
Cleared Feb 18, 1994
NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM
K931410
Novus Technologies, Inc.
Radiology · 336d
Cleared Jan 28, 1994
OLYMPUS IMAGEMANAGER SYSTEM
K934889
Olympus
Radiology · 107d
Cleared Jan 25, 1994
OLYMPUS IMAGEMANAGERSYSTEM
K934888
Olympus
Radiology · 104d
Cleared Nov 19, 1993
SC1000 SCAN CONVERTER
K926348
Perkins Mfg. Co.
Radiology · 337d
Cleared Oct 20, 1992
ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM
K923680
Minnetonka Medical
Radiology · 90d
Cleared Jun 10, 1992
SONY LASER VIDEODISC RECORDING SYSTEM
K921275
Sony Medical Systems
Radiology · 82d
Cleared Mar 02, 1992
KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
K914728
Eastman Kodak Company
Radiology · 133d
Cleared Dec 27, 1991
VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM
K915094
Vortech Data, Inc.
Radiology · 45d
Cleared Dec 18, 1991
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
K905488
Ausonics Pty , Ltd.
Radiology · 376d
Cleared Nov 23, 1990
ANGIOTEC IMAGE MANAGEMENT SYSTEM
K903806
Andros Analyzers, Inc.
Radiology · 95d
Cleared Jul 02, 1990
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
K901956
Eigen
Radiology · 62d
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 May 05, 1989
ANGIOTEC FMX-2220 SYSTEM
K891485
Andros Analyzers, Inc.
Radiology · 49d
Cleared Mar 23, 1989
IMS-3 PICTURE ARCHIVING SYSTEM
K884990
The Biomedical Engineering Center
Radiology · 112d
Cleared Nov 23, 1988
DISKCAM DC 6001
K884148
Camtronics, Ltd.
Radiology · 51d