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
97–120 of 142
Cleared Dec 13, 1993
PRACTICE PARTNER
K926315
Rs Imaging
Radiology · 363d
Cleared Nov 22, 1993
PHOTOPHONE MULTIVIEW
K931186
Image Data Corp.
Radiology · 258d
Cleared Nov 19, 1993
TELERAD STAT
K931795
Magnetic Research, Inc.
Radiology · 221d
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 Sep 20, 1993
COURIER PC
K925864
Shoreline Business Consulting
Radiology · 305d
Cleared Sep 20, 1993
MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL
K933098
Siemens Medical Solutions Health Services Corporat
Radiology · 88d
Cleared Jul 29, 1993
MULTIVIEW FOR WINDOWS
K931292
Image Data Corp.
Radiology · 139d
Cleared Jun 29, 1993
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K931551
Eastman Kodak Company
Radiology · 92d
Cleared Jun 25, 1993
DIGIRAY
K926098
Telescan Corp.
Radiology · 204d
Cleared May 20, 1993
STATVIEW
K931060
Image Data Corp.
Radiology · 80d
Cleared May 03, 1993
PC TELERADIOLOGY(TM)
K925050
Arizona State Radiology
Radiology · 209d
Cleared Apr 27, 1993
RADMAN IMAGE MANAGMENT SYSTEM
K930350
Infocure Systems, Inc.
Radiology · 92d
Cleared Apr 07, 1993
DOMINATOR RADIOLOGY SYSTEM
K930997
Dominator Radiology Systems, Inc.
Radiology · 65d
Cleared Mar 29, 1993
TELEMEDIC TELERADIOLOGY SYSTEM
K921185
Meditron Corp.
Radiology · 385d
Cleared Mar 18, 1993
RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)
K925994
Rstar, Inc.
Radiology · 111d
Cleared Mar 15, 1993
RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)
K925929
Rstar, Inc.
Radiology · 112d
Cleared Feb 02, 1993
MEDVISION(TM) IMAGING SOFTWARE
K924178
Evergreen Technologies, Inc.
Radiology · 167d
Cleared Jan 21, 1993
RAYTEL DIGITAL IMAGING SYSTEMS
K922164
Olicon Imaging Systems, Inc.
Radiology · 258d
Cleared Jan 21, 1993
IMAGESSSHARE 910
K925284
Dejarnette Research Systems
Radiology · 93d
Cleared Jan 15, 1993
VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)
K925097
Vortech Data, Inc.
Radiology · 99d
Cleared Nov 27, 1992
VG-A MIG
K924229
Vortech Data, Inc.
Radiology · 98d
Cleared Oct 14, 1992
SIENET CAMERA SERVER
K923582
Siemens Gammasonics, Inc.
Radiology · 86d
Cleared Jul 01, 1992
AD/V SPOOLER
K921877
Adaptive Video, Inc.
Radiology · 72d