FDA 510(k) Applications for Medical Device Product Code "LMD"
(System, Digital Image Communications, Radiological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972925 | ACCESS RADIOLOGY CORP. | ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC | 12/05/1997 |
| K954691 | ACCESS RADIOLOGY CORP. | ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM | 03/29/1996 |
| K961023 | ACCUIMAGE, INC. | AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) | 09/09/1996 |
| K973239 | ADAC LABORATORIES | DICOM 3.0 SOFTWARE VERSION 2.0 | 11/26/1997 |
| K962699 | APPLICARE MEDICAL IMAGING, B.V. | RADWORKS MEDICAL IMAGING SOFTWARE | 08/19/1996 |
| K970064 | AUTOCYT GROUP, INC. | AMICAS WEB/INTRANET IMAGE SERVER | 03/17/1997 |
| K980541 | BARCO NV DISPLAY SYSTEMS | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY | 04/09/1998 |
| K972701 | BARCO NV DISPLAY SYSTEMS | BARCO MWD 321 MEDICAL WORKSTATION DISPLAY | 01/02/1998 |
| K955000 | CERNER CORP. | REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE | 01/26/1996 |
| K955708 | COMPUMED, INC. | COMPUMED DICON CLIENT | 03/01/1996 |
| K963628 | DEJARNETTE RESEARCH SYSTEMS | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE | 11/07/1996 |
| K973421 | DEJARNETTE RESEARCH SYSTEMS | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} | 12/05/1997 |
| K963592 | DEJARNETTE RESEARCH SYSTEMS | IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 | 11/07/1996 |
| K963594 | DEJARNETTE RESEARCH SYSTEMS | IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) | 11/07/1996 |
| K963861 | DEJARNETTE RESEARCH SYSTEMS | LASERSHARE PRINT SPOOLER AND/OR SOFTWARE | 12/18/1996 |
| K974130 | DEJARNETTE RESEARCH SYSTEMS | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE | 01/29/1998 |
| K960382 | EASTMAN KODAK COMPANY | KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER | 04/17/1996 |
| K974107 | EASTMAN KODAK COMPANY | KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) | 01/21/1998 |
| K981053 | EASTMAN KODAK COMPANY | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW | 06/18/1998 |
| K974255 | ELECTROMED INTL., LTD. | CD-R STATION AND VRS-2000 | 01/27/1998 |
| K970293 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 | 03/21/1997 |
| K970628 | GE MEDICAL SYSTEMS, INC. | GE ADVANTAGE DIGITIZER WORKSTATION | 05/12/1997 |
| K954479 | HEARTLAB, INC. | DICOMVIEW | 02/21/1996 |
| K972191 | HOWTEK, INC. | DIGITIZER DIRECTOR (HSC025-01) | 09/08/1997 |
| K980684 | I.S.G. TECHNOLOGIES, INC. | VR NETSERVE | 05/06/1998 |
| K954071 | IDX SYSTEMS CORP. | IDXVIEW | 02/27/1996 |
| K954172 | IMAGE VISIONS, LLC. | X-RAY VISIONS | 03/15/1996 |
| K961753 | IMAGELABS, INC. | SHARED VISION(PART NUMBER SV 0015) | 07/25/1996 |
| K973303 | IMATION CORP. | IMATION MODEL 9410 NETWORK INTERFACE | 11/25/1997 |
| K972366 | IMNET SYSTEMS, INC. | IMNET DICOM NETWORK AGENT | 09/23/1997 |
| K961689 | INFIMED, INC. | INFINET | 07/31/1996 |
| K992352 | INTELERADIOLOGY, INC. | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 | 09/29/1999 |
| K971347 | INTERNATIONAL REGULATORY CONSULTANTS | MEDISURF | 07/03/1997 |
| K962225 | KLT TELECOM, INC. | VIEWSEND MEDICAL MODEL 1200 | 10/25/1996 |
| K974882 | MERLIN ENGINEERING WORKS, INC. | DOWNSCAN LT | 05/22/1998 |
| K971154 | MERLIN ENGINEERING WORKS, INC. | MULTIPICS(ME-977) | 06/25/1997 |
| K971153 | MERLIN ENGINEERING WORKS, INC. | SPLITSCREEN (ME-975) | 06/25/1997 |
| K974102 | MITRA IMAGING, INC. | MILTRA IMAGING INC., IMAGE VAULT | 01/20/1998 |
| K970652 | MITRA IMAGING, INC. | MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE | 05/02/1997 |
| K980241 | NETCO COMMUNICATIONS CORP. | NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE | 03/17/1998 |
| K973959 | OLICON IMAGING SYSTEMS, INC. | OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE | 12/22/1997 |
| K973793 | OLICON IMAGING SYSTEMS, INC. | OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE | 12/17/1997 |
| K960809 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. | PHILIPS SITE VIEW WORKSTATION | 04/07/1996 |
| K980918 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | JPACS | 06/03/1998 |
| K970174 | PIXELINKS, INC. | FREEPIX/PIXPACS DICOM/HTTP GATEWAY | 05/01/1997 |
| K973090 | PROGRAM S.R.L. | MEDSTATION | 10/28/1997 |
| K970641 | RADIOLOGY INFORMATION SYSTEMS, INC. | RIS SCANVIEW SYSTEM (RSVS) | 05/02/1997 |
| K954567 | RADIOLOGY TELENETWORK INTL. | RTI MEDICAL | 04/12/1996 |
| K992426 | SAMSUNG SDS CO., LTD | RAYPAX WEB CLINICAL SYSTEM | 10/13/1999 |
| K991537 | SAMSUNG SDS CO., LTD | SAMSUNG RAYPAX SYSTEM | 07/06/1999 |
| K960911 | SCIMAGE, INC. | NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE | 05/29/1996 |
| K965161 | SECTRA-IMTEC AB | SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) | 03/12/1997 |
| K973131 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) | 11/12/1997 |
| K992698 | STENTOR, INC. | STENTOR, PAGEVIEW | 10/25/1999 |
| K980220 | STERLING DIAGNOSTIC IMAGING, INC. | IISYS PACS SYSTEM | 02/13/1998 |
| K964250 | STERLING DIAGNOSTIC IMAGING, INC. | LINX NETWORKING SYSTEM | 12/18/1996 |
| K973805 | STORCOMM, INC. | IMAGEACCESS SYSTEM | 01/02/1998 |
| K984000 | SURGICAL NAVIGATION TECHNOLOGIES, INC. | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | 01/12/1999 |
| K994329 | TERARECON, INC. | IIVS INTEGRATED IMAGE VIEWING STATION | 05/26/2000 |
| K974707 | VISUAL MED, INC. | IMAGEQUEST | 07/31/1998 |
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