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 Vortech Data, Inc..

142
Total
142
Cleared
123d
Avg days
1985
Since
142 devices
121–142 of 142
Cleared Jun 24, 1992
STATVIEW
K921527
Image Data Corp.
Radiology · 82d
Cleared May 27, 1992
3M DIGITAL DISK INTERFACE UNIT
K920268
3M Company
Radiology · 127d
Cleared May 18, 1992
M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION
K921278
Metecon, Inc.
Radiology · 62d
Cleared Mar 30, 1992
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
K920310
Siemens Gammasonics, Inc.
Radiology · 67d
Cleared Feb 27, 1992
XPR PRINTER REDUNDANCY
K914444
Vortech Data, Inc.
Radiology · 146d
Cleared Feb 18, 1992
XLP NETWORK PRINTING
K914191
Vortech Data, Inc.
Radiology · 153d
Cleared Jun 28, 1991
PHILIPS TELESCAN
K911773
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Apr 23, 1991
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
K911405
Eastman Kodak Company
Radiology · 25d
Cleared Jan 14, 1991
PACSNET RESEARCH TOOLKIT
K905199
Siemens Gammasonics, Inc.
Radiology · 55d
Cleared May 15, 1990
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
K900935
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 76d
Cleared Feb 16, 1990
IMAGES-ON-CALL TELERADIOLOGY SYSTEM
K896095
Devices & Services Co.
Radiology · 119d
Cleared Feb 12, 1990
MVP (MULTI-VENDOR PROTOCOL CONVERTOR)
K900227
Merge Technologies, Inc.
Radiology · 26d
Cleared Oct 27, 1989
FILMFAX
K895209
Discovery Systems, Inc.
Radiology · 71d
Cleared Apr 06, 1989
MEDI-TRACE THERMAL VIDEO FILM PAPER
K891192
Graphic Controls Corp.
Radiology · 31d
Cleared Jan 19, 1989
VORTECH'S MEDICAL IMAGING GATEWAY
K884434
Vortech Data, Inc.
Radiology · 91d
Cleared Oct 21, 1988
REPORT AND IMAGE MANAGEMENT SYSTEM
K882754
Medical Image Processing Specialists, Inc.
Radiology · 108d
Cleared Aug 23, 1988
GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
K873121
General Electric Co.
Radiology · 378d
Cleared Aug 12, 1987
KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE
K871984
Eastman Kodak Company
Radiology · 82d
Cleared Nov 28, 1986
AVP TELEIMAGING SYSTEM
K862158
Advanced Video Products, Inc.
Radiology · 175d
Cleared Nov 26, 1986
TELERADIOGRAPHY SYSTEM
K862744
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 128d
Cleared Oct 16, 1986
COMMVIEW SYSTEM
K862715
A T & T Technologies, Inc.
Radiology · 91d
Cleared Oct 16, 1985
INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK
K850417
Impact Systems Corp.
Radiology · 254d