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, Base Ten Systems, Inc. and Sectra-Imtec AB.

55
Total
55
Cleared
120d
Avg days
1983
Since

FDA 510(k) Cleared Device, Digital Image Storage, Radiological Devices (Product Code LMB)

55 devices
1–24 of 55
Cleared Sep 13, 1999
SAMSUNG RAYPAX LONG TERM ARCHIVE
K992131
Samsung Sds Co., Ltd.
Radiology · 82d
Cleared Feb 08, 1999
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
K984405
Intracom Corp.
Radiology · 61d
Cleared Oct 29, 1998
WISE (II) IMAGE MANAGEMENT SYSTEM
K983447
Sectra-Imtec AB
Radiology · 29d
Cleared Apr 03, 1998
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
K980243
Parameter Developments, Inc.
Radiology · 70d
Cleared Dec 02, 1997
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K973463
O Tech, Inc.
Radiology · 81d
Cleared Nov 25, 1997
ID. STORE (RELEASE 2.0)
K973413
I.S.G. Technologies, Inc.
Radiology · 77d
Cleared Sep 11, 1997
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
K972380
Eastman Kodak Company
Radiology · 77d
Cleared Aug 15, 1997
TDK MEDICAL GRADE CD-R
K971848
Tdk Electronics Corporation of America
Radiology · 88d
Cleared Jun 26, 1997
WISE IMAGE MANAGEMENT SYSTEM
K971451
O Tech, Inc.
Radiology · 66d
Cleared Mar 31, 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936
Biosound, Inc.
Radiology · 181d
Cleared Feb 11, 1997
UNIVISION ECHOCARDIOLOGY SYSTEM
K964803
Network Concepts, Inc.
Radiology · 74d
Cleared Jan 10, 1997
WRITESTAR, AND VIEWSTAR
K964274
Comview Corp.
Radiology · 77d
Cleared Oct 25, 1996
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
K963395
Sectra-Imtec AB
Radiology · 58d
Cleared Jul 03, 1996
SONY DKR-700 DIGITAL STILL RECORDER
K961680
Sony Medical Systems
Radiology · 63d
Cleared Jun 11, 1996
UPACS VERSION 1.7
K961160
Base Ten Systems, Inc.
Radiology · 81d
Cleared Jun 07, 1996
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
K960981
Kodak Health Imaging Systems, Inc.
Radiology · 88d
Cleared Jun 03, 1996
UPACS
K960941
Base Ten Systems, Inc.
Radiology · 87d
Cleared Apr 08, 1996
LAST IMAGE HOLD
K951942
Insight Systems
Radiology · 348d
Cleared Apr 04, 1996
TIGERSCAN/TIGERVIEW
K955237
Tau Corp.
Radiology · 142d
Cleared Mar 07, 1996
FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM
K960326
Fujifilm Medical System U.S.A., Inc.
Radiology · 43d
Cleared Feb 21, 1996
VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)
K952238
Imaging Concepts, Inc.
Radiology · 285d
Cleared Jan 24, 1996
ACCULUPE
K955184
E For M Imaging Systems Div., Marquette Electronic
Radiology · 72d
Cleared Dec 11, 1995
NT SERIES DIGITAL IMAGE MANAGER
K955232
Camtronics, Ltd.
Radiology · 27d
Cleared Nov 22, 1995
WALLACH DIGITAL IMAGING SYSTEM
K950630
Wallach Surgical Devices, Inc.
Radiology · 282d

About Product Code LMB - Regulatory Context