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 Dejarnette Research Systems, Eastman Kodak Company and Vortech Data, Inc..

142
Total
142
Cleared
123d
Avg days
1985
Since
142 devices
49–72 of 142
Cleared Jul 31, 1996
INFINET
K961689
Infimed, Inc.
Radiology · 91d
Cleared Jul 25, 1996
SHARED VISION(PART NUMBER SV 0015)
K961753
Imagelabs, Inc.
Radiology · 80d
Cleared May 29, 1996
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
K960911
Scimage, Inc.
Radiology · 84d
Cleared Apr 17, 1996
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382
Eastman Kodak Company
Radiology · 83d
Cleared Apr 12, 1996
RTI MEDICAL
K954567
Radiology Telenetwork Intl.
Radiology · 196d
Cleared Apr 07, 1996
PHILIPS SITE VIEW WORKSTATION
K960809
Philips Medical Systems North America, Inc.
Radiology · 39d
Cleared Mar 29, 1996
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM
K954691
Access Radiology Corp.
Radiology · 170d
Cleared Mar 15, 1996
X-RAY VISIONS
K954172
Image Visions, LLC
Radiology · 192d
Cleared Mar 01, 1996
COMPUMED DICON CLIENT
K955708
Compumed, Inc.
Radiology · 78d
Cleared Feb 27, 1996
IDXVIEW
K954071
Idx Systems Corp.
Radiology · 181d
Cleared Feb 21, 1996
DICOMVIEW
K954479
Heartlab, Inc.
Radiology · 148d
Cleared Jan 26, 1996
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
K955000
Cerner Corp.
Radiology · 86d
Cleared Nov 13, 1995
ARCHIVEMANAGER
K950513
Cemax, Inc.
Radiology · 280d
Cleared Oct 27, 1995
REDI-VU SYSTEMS (SEND & RECEIVE)
K954008
Jd Technical Services, Inc.
Radiology · 63d
Cleared Oct 24, 1995
SIENET SPI SPOOLER
K953552
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Oct 18, 1995
LUMISYS DICOM TOOKLIT
K953371
Lumisys, Inc.
Radiology · 92d
Cleared Oct 07, 1995
COURIER II
K953514
Gammex, Inc.
Radiology · 73d
Cleared Oct 06, 1995
UNISCAN
K953398
Merlin Engineering Works, Inc.
Radiology · 78d
Cleared Sep 28, 1995
DIGITAL IMAGING SYSTEM INTERFACE
K953080
Camtronics, Ltd.
Radiology · 87d
Cleared Sep 22, 1995
QUICK READ 2000 (QR2000)
K953163
Quicksilver Systems, Inc.
Radiology · 77d
Cleared Sep 18, 1995
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM
K952914
Star Technologies, Inc.
Radiology · 84d
Cleared Aug 23, 1995
SIENET DICOM GATEWAY
K952533
Siemens AG
Radiology · 83d
Cleared Jun 30, 1995
MEDIPACS
K950413
Nexsys Electronics
Radiology · 150d
Cleared Jun 30, 1995
MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS)
K951175
Sirius Corp.
Radiology · 107d