LMB — Device, Digital Image Storage, Radiological

21 CFR 892.2010

Class 1

Definition

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (55)

Device Name	Manufacturer	K-Number	Decision Date
SAMSUNG RAYPAX LONG TERM ARCHIVE	Samsung Sds Co., Ltd.	K992131	1999-09-13
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000	Intracom Corp.	K984405	1999-02-08
WISE (II) IMAGE MANAGEMENT SYSTEM	Sectra-Imtec AB	K983447	1998-10-29
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)	Parameter Developments, Inc.	K980243	1998-04-03
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE	O Tech, Inc.	K973463	1997-12-02
ID. STORE (RELEASE 2.0)	I.S.G. Technologies, Inc.	K973413	1997-11-25
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)	Eastman Kodak Company	K972380	1997-09-11
TDK MEDICAL GRADE CD-R	Tdk Electronics Corporation of America	K971848	1997-08-15
WISE IMAGE MANAGEMENT SYSTEM	O Tech, Inc.	K971451	1997-06-26
ACCESSPOINT, MED E-MAIL, DICOM READER	Biosound, Inc.	K963936	1997-03-31
UNIVISION ECHOCARDIOLOGY SYSTEM	Network Concepts, Inc.	K964803	1997-02-11
WRITESTAR, AND VIEWSTAR	Comview Corp.	K964274	1997-01-10
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM	Sectra-Imtec AB	K963395	1996-10-25
SONY DKR-700 DIGITAL STILL RECORDER	Sony Medical Systems	K961680	1996-07-03
UPACS VERSION 1.7	Base Ten Systems, Inc.	K961160	1996-06-11
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY	Kodak Health Imaging Systems, Inc.	K960981	1996-06-07
UPACS	Base Ten Systems, Inc.	K960941	1996-06-03
LAST IMAGE HOLD	Insight Systems	K951942	1996-04-08
TIGERSCAN/TIGERVIEW	Tau Corp.	K955237	1996-04-04
FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM	Fujifilm Medical System U.S.A., Inc.	K960326	1996-03-07

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