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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