FDA 510(k) Applications for Medical Device Product Code "LMB"
(Device, Digital Image Storage, Radiological)

FDA 510(k) Number Applicant Device Name Decision Date
K960941 BASE TEN SYSTEMS, INC. UPACS 06/03/1996
K961160 BASE TEN SYSTEMS, INC. UPACS VERSION 1.7 06/11/1996
K963936 BIOSOUND, INC. ACCESSPOINT, MED E-MAIL, DICOM READER 03/31/1997
K964274 COMVIEW CORP. WRITESTAR, AND VIEWSTAR 01/10/1997
K955184 E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC ACCULUPE 01/24/1996
K972380 EASTMAN KODAK COMPANY KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) 09/11/1997
K960326 FUJIFILM MEDICAL SYSTEM U.S.A., INC. FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM 03/07/1996
K973413 I.S.G. TECHNOLOGIES, INC. ID. STORE (RELEASE 2.0) 11/25/1997
K952238 IMAGING CONCEPTS, INC. VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) 02/21/1996
K951942 INSIGHT SYSTEMS LAST IMAGE HOLD 04/08/1996
K984405 INTRACOM CORP. ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 02/08/1999
K960981 KODAK HEALTH IMAGING SYSTEMS, INC. KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY 06/07/1996
K964803 NETWORK CONCEPTS, INC. UNIVISION ECHOCARDIOLOGY SYSTEM 02/11/1997
K973463 OTECH, INC. OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE 12/02/1997
K971451 OTECH, INC. WISE IMAGE MANAGEMENT SYSTEM 06/26/1997
K980243 PARAMETER DEVELOPMENTS, INC. PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) 04/03/1998
K992131 SAMSUNG SDS CO., LTD SAMSUNG RAYPAX LONG TERM ARCHIVE 09/13/1999
K963395 SECTRA-IMTEC AB IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM 10/25/1996
K983447 SECTRA-IMTEC AB WISE (II) IMAGE MANAGEMENT SYSTEM 10/29/1998
K961680 SONY MEDICAL SYSTEMS SONY DKR-700 DIGITAL STILL RECORDER 07/03/1996
K955237 TAU CORP. TIGERSCAN/TIGERVIEW 04/04/1996
K971848 TDK ELECTRONICS CORPORATION OF AMERICA TDK MEDICAL GRADE CD-R 08/15/1997


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