System, Digital Image Communications, Radiological
Regulation 892.2020
0510(k)s in 12 months (142 all time)
0recalls in 12 months (12 all time)
3recalls that name a 510(k)
Top companies in LMD
| Company | 510(k)s | Recalls |
|---|---|---|
| Dejarnette Research Systems | 7 | 0 |
| Eastman Kodak Company | 7 | 0 |
| Siemens Medical Solutions USA, Inc. | 2 | 3 |
| Vortech Data, Inc. | 5 | 0 |
| Image Data Corp. | 4 | 0 |
| Merlin Engineering Works, Inc. | 4 | 0 |
| Advanced Video Products, Inc. | 3 | 0 |
| Evergreen Technologies, Inc. | 3 | 0 |
| Olicon Imaging Systems, Inc. | 3 | 0 |
| Siemens Gammasonics, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 2000 | K994329 | IIVS INTEGRATED IMAGE VIEWING STATION Terarecon,Inc. | LMD |
| Oct 25, 1999 | K992698 | STENTOR, PAGEVIEW Stentor, Inc. | LMD |
| Oct 13, 1999 | K992426 | RAYPAX WEB CLINICAL SYSTEM Samsung Sds Co., Ltd. | LMD |
| Sep 29, 1999 | K992352 | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 Inteleradiology, Inc. | LMD |
| Jul 6, 1999 | K991537 | SAMSUNG RAYPAX SYSTEM Samsung Sds Co., Ltd. | LMD |
| Jan 12, 1999 | K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM Surgical Navigation Technologies, Inc. | LMD |
| Jul 31, 1998 | K974707 | IMAGEQUEST Visual Med, Inc. | LMD |
| Jun 18, 1998 | K981053 | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW Eastman Kodak Company | LMD |
| Jun 3, 1998 | K980918 | JPACS Philips Medical Systems (Cleveland), Inc. | LMD |
| May 22, 1998 | K974882 | DOWNSCAN LT Merlin Engineering Works, Inc. | LMD |
| May 6, 1998 | K980684 | VR NETSERVE I.S.G. Technologies, Inc., CA | LMD |
| Apr 9, 1998 | K980541 | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY Barco NV Display Systems | LMD |
| Mar 17, 1998 | K980241 | NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE Netco Communications Corp. | LMD |
| Feb 13, 1998 | K980220 | IISYS PACS SYSTEM Sterling Diagnostic Imaging, Inc. | LMD |
| Jan 29, 1998 | K974130 | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE Dejarnette Research Systems | LMD |
| Jan 27, 1998 | K974255 | CD-R STATION AND VRS-2000 Electromed Intl., Ltd., CA | LMD |
| Jan 21, 1998 | K974107 | KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) Eastman Kodak Company | LMD |
| Jan 20, 1998 | K974102 | MILTRA IMAGING INC., IMAGE VAULT Mitra Imaging, Inc. | LMD |
| Jan 2, 1998 | K973805 | IMAGEACCESS SYSTEM Storcomm, Inc. | LMD |
| Jan 2, 1998 | K972701 | BARCO MWD 321 MEDICAL WORKSTATION DISPLAY Barco NV Display Systems | LMD |
| Dec 22, 1997 | K973959 | OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE Olicon Imaging Systems, Inc. | LMD |
| Dec 17, 1997 | K973793 | OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE Olicon Imaging Systems, Inc. | LMD |
| Dec 5, 1997 | K973421 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} Dejarnette Research Systems | LMD |
| Dec 5, 1997 | K972925 | ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC Access Radiology Corp. | LMD |
| Nov 26, 1997 | K973239 | DICOM 3.0 SOFTWARE VERSION 2.0 Adac Laboratories | LMD |
| Nov 25, 1997 | K973303 | IMATION MODEL 9410 NETWORK INTERFACE Imation Corp. | LMD |
| Nov 12, 1997 | K973131 | SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) Siemens Medical Solutions USA, Inc. | LMD |
| Oct 28, 1997 | K973090 | MEDSTATION Program S.R.L. | LMD |
| Sep 23, 1997 | K972366 | IMNET DICOM NETWORK AGENT Imnet Systems, Inc. | LMD |
| Sep 8, 1997 | K972191 | DIGITIZER DIRECTOR (HSC025-01) Howtek, Inc. | LMD |
| Jul 3, 1997 | K971347 | MEDISURF International Regulatory Consultants, IL | LMD |
| Jun 25, 1997 | K971154 | MULTIPICS(ME-977) Merlin Engineering Works, Inc. | LMD |
| Jun 25, 1997 | K971153 | SPLITSCREEN (ME-975) Merlin Engineering Works, Inc. | LMD |
| May 12, 1997 | K970628 | GE ADVANTAGE DIGITIZER WORKSTATION Ge Medical Systems, Inc. | LMD |
| May 2, 1997 | K970652 | MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE Mitra Imaging, Inc., CA | LMD |
| May 2, 1997 | K970641 | RIS SCANVIEW SYSTEM (RSVS) Radiology Information Systems, Inc. | LMD |
| May 1, 1997 | K970174 | FREEPIX/PIXPACS DICOM/HTTP GATEWAY Pixelinks, Inc. | LMD |
| Mar 21, 1997 | K970293 | FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 Fujifilm Medical System U.S.A., Inc. | LMD |
| Mar 17, 1997 | K970064 | AMICAS WEB/INTRANET IMAGE SERVER Autocyt Group, Inc. | LMD |
| Mar 12, 1997 | K965161 | SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) Sectra-Imtec AB | LMD |
| Dec 18, 1996 | K964250 | LINX NETWORKING SYSTEM Sterling Diagnostic Imaging, Inc. | LMD |
| Dec 18, 1996 | K963861 | LASERSHARE PRINT SPOOLER AND/OR SOFTWARE Dejarnette Research Systems | LMD |
| Nov 7, 1996 | K963628 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE Dejarnette Research Systems | LMD |
| Nov 7, 1996 | K963594 | IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) Dejarnette Research Systems | LMD |
| Nov 7, 1996 | K963592 | IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 Dejarnette Research Systems | LMD |
| Oct 25, 1996 | K962225 | VIEWSEND MEDICAL MODEL 1200 Klt Telecom, Inc. | LMD |
| Sep 9, 1996 | K961023 | AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) Accuimage, Inc. | LMD |
| Aug 19, 1996 | K962699 | RADWORKS MEDICAL IMAGING SOFTWARE Applicare Medical Imaging, B.V. | LMD |
| Jul 31, 1996 | K961689 | INFINET Infimed, Inc. | LMD |
| Jul 25, 1996 | K961753 | SHARED VISION(PART NUMBER SV 0015) Imagelabs, Inc. | LMD |
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