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, Siemens Gammasonics, Inc. and Siemens Medical Solutions USA, Inc..

142
Total
142
Cleared
123d
Avg days
1985
Since

FDA 510(k) Cleared System, Digital Image Communications, Radiological Devices (Product Code LMD)

142 devices
1–24 of 142
Cleared Jun 18, 1998
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
K981053
Eastman Kodak Company
Radiology · 87d
Cleared Jun 03, 1998
JPACS
K980918
Philips Medical Systems (Cleveland), Inc.
Radiology · 84d
Cleared Jan 21, 1998
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
K974107
Eastman Kodak Company
Radiology · 82d
Cleared Nov 26, 1997
DICOM 3.0 SOFTWARE VERSION 2.0
K973239
Adac Laboratories
Radiology · 90d
Cleared Nov 12, 1997
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K973131
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared May 12, 1997
GE ADVANTAGE DIGITIZER WORKSTATION
K970628
Ge Medical Systems, Inc.
Radiology · 82d
Cleared Mar 21, 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293
Fujifilm Medical System U.S.A., Inc.
Radiology · 56d
Cleared Apr 17, 1996
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382
Eastman Kodak Company
Radiology · 83d
Cleared Apr 07, 1996
PHILIPS SITE VIEW WORKSTATION
K960809
Philips Medical Systems North America, Inc.
Radiology · 39d
Cleared Oct 24, 1995
SIENET SPI SPOOLER
K953552
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jun 23, 1995
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K952484
Toshiba America Medical Systems, In.C
Radiology · 24d
Cleared Jul 29, 1994
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
K940423
Advanced Technology Laboratories, Inc.
Radiology · 179d
Cleared Apr 29, 1994
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116
Eastman Kodak Company
Radiology · 127d
Cleared Jan 05, 1994
IMPAX 5000
K934386
Heraeus Kulzer, Inc.
Radiology · 119d
Cleared Nov 03, 1993
IMPAX 1000
K933409
Heraeus Kulzer, Inc.
Radiology · 114d
Cleared Jun 29, 1993
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K931551
Eastman Kodak Company
Radiology · 92d
Cleared Oct 14, 1992
SIENET CAMERA SERVER
K923582
Siemens Gammasonics, Inc.
Radiology · 86d
Cleared May 27, 1992
3M DIGITAL DISK INTERFACE UNIT
K920268
3M Company
Radiology · 127d
Cleared Mar 30, 1992
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
K920310
Siemens Gammasonics, Inc.
Radiology · 67d
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 Apr 06, 1989
MEDI-TRACE THERMAL VIDEO FILM PAPER
K891192
Graphic Controls Corp.
Radiology · 31d

About Product Code LMD - Regulatory Context