LMD · Class I · 21 CFR 892.2020

FDA Product Code LMD: System, Digital Image Communications, Radiological

A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.

Leading manufacturers include Eastman Kodak Company, Dejarnette Research Systems and Siemens Gammasonics, Inc..

142
Total
142
Cleared
123d
Avg days
1985
Since
142 devices
25–48 of 142
Cleared Nov 26, 1997
DICOM 3.0 SOFTWARE VERSION 2.0
K973239
Adac Laboratories
Radiology · 90d
Cleared Nov 25, 1997
IMATION MODEL 9410 NETWORK INTERFACE
K973303
Imation Corp.
Radiology · 83d
Cleared Nov 12, 1997
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K973131
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Oct 28, 1997
MEDSTATION
K973090
Program S.R.L.
Radiology · 71d
Cleared Sep 23, 1997
IMNET DICOM NETWORK AGENT
K972366
Imnet Systems, Inc.
Radiology · 90d
Cleared Sep 08, 1997
DIGITIZER DIRECTOR (HSC025-01)
K972191
Howtek, Inc.
Radiology · 90d
Cleared Jul 03, 1997
MEDISURF
K971347
International Regulatory Consultants
Radiology · 84d
Cleared Jun 25, 1997
SPLITSCREEN (ME-975)
K971153
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Jun 25, 1997
MULTIPICS(ME-977)
K971154
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared May 12, 1997
GE ADVANTAGE DIGITIZER WORKSTATION
K970628
Ge Medical Systems, Inc.
Radiology · 82d
Cleared May 02, 1997
RIS SCANVIEW SYSTEM (RSVS)
K970641
Radiology Information Systems, Inc.
Radiology · 71d
Cleared May 02, 1997
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
K970652
Mitra Imaging, Inc.
Radiology · 70d
Cleared May 01, 1997
FREEPIX/PIXPACS DICOM/HTTP GATEWAY
K970174
Pixelinks, Inc.
Radiology · 111d
Cleared Mar 21, 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293
Fujifilm Medical System U.S.A., Inc.
Radiology · 56d
Cleared Mar 17, 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064
Autocyt Group, Inc.
Radiology · 69d
Cleared Mar 12, 1997
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K965161
Sectra-Imtec AB
Radiology · 79d
Cleared Dec 18, 1996
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
K963861
Dejarnette Research Systems
Radiology · 85d
Cleared Dec 18, 1996
LINX NETWORKING SYSTEM
K964250
Sterling Diagnostic Imaging, Inc.
Radiology · 55d
Cleared Nov 07, 1996
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
K963592
Dejarnette Research Systems
Radiology · 59d
Cleared Nov 07, 1996
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
K963594
Dejarnette Research Systems
Radiology · 59d
Cleared Nov 07, 1996
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K963628
Dejarnette Research Systems
Radiology · 57d
Cleared Oct 25, 1996
VIEWSEND MEDICAL MODEL 1200
K962225
Klt Telecom, Inc.
Radiology · 137d
Cleared Sep 09, 1996
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
K961023
Accuimage, Inc.
Radiology · 179d
Cleared Aug 19, 1996
RADWORKS MEDICAL IMAGING SOFTWARE
K962699
Applicare Medical Imaging, B.V.
Radiology · 39d