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
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 Oct 24, 1995
SIENET SPI SPOOLER
K953552
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Sep 28, 1995
DIGITAL IMAGING SYSTEM INTERFACE
K953080
Camtronics, Ltd.
Radiology · 87d
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 Oct 05, 1993
DIGITAL IMAGE COMMUNICATIONS SYSTEM
K933103
Analogic Corp.
Radiology · 103d
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