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
73–96 of 142
Cleared Jun 23, 1995
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K952484
Toshiba America Medical Systems, In.C
Radiology · 24d
Cleared May 12, 1995
PACS EQUIPMENT
K943994
Rstar Image Management System
Radiology · 269d
Cleared May 04, 1995
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
K950431
Open Mri, Inc.
Radiology · 91d
Cleared May 03, 1995
PREVIEW TELEIMAGING SYSTEM
K950699
Regulatory Management Services
Radiology · 77d
Cleared Apr 12, 1995
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
K950343
Rogan Imaging Corp.
Radiology · 75d
Cleared Feb 24, 1995
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM
K944322
At&T Image Solutions
Radiology · 175d
Cleared Feb 03, 1995
IMAGE TRANSPORT SERIES III
K925964
Dataview Imaging Intl., Inc.
Radiology · 800d
Cleared Feb 01, 1995
PACSPRO I
K940859
Advanced Video Products, Inc.
Radiology · 343d
Cleared Jan 26, 1995
INTRASCAN II
K944771
Markcare Medical Systems, Inc.
Radiology · 121d
Cleared Dec 23, 1994
RIT 531 TELERADIOLOGY/ PAC SYSTEM
K944130
Radiological Imaging Technology, Inc.
Radiology · 121d
Cleared Dec 09, 1994
LENZAR REMOTE ACQUISITION SYSTEM
K941224
Lenzar Electrooptics, Inc.
Radiology · 270d
Cleared Dec 07, 1994
MEDVISION ENVIROMENT/MEDVISION 2.0
K942861
Evergreen Technologies, Inc.
Radiology · 173d
Cleared Nov 22, 1994
AD/V IMAGEPLEX(TM)
K943158
Adaptive Video, Inc.
Radiology · 144d
Cleared Nov 22, 1994
IMAGING WORKBENCH
K943383
Brit Systems, Inc.
Radiology · 132d
Cleared Nov 14, 1994
ULTRAPRO WORKSTATION
K942917
Ramsoft, Inc.
Radiology · 146d
Cleared Jul 29, 1994
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
K940423
Advanced Technology Laboratories, Inc.
Radiology · 179d
Cleared Jun 27, 1994
PACSPRO II
K941086
Advanced Video Products, Inc.
Radiology · 111d
Cleared Jun 27, 1994
MEDICAL IMAGING WORKSTATION II (MIW II)
K941203
Cemco, Inc.
Radiology · 105d
Cleared Jun 08, 1994
REMOTE CONSOLE
K940408
Robinson Engineering Teleradiology System
Radiology · 133d
Cleared May 23, 1994
3M 1156 MULTI-INPUT SYSTEM
K936153
3M Information,Imaging and Electronic Sector
Radiology · 147d
Cleared Apr 29, 1994
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116
Eastman Kodak Company
Radiology · 127d
Cleared Feb 09, 1994
VISIONLINK ACR-NEMA CONVERSION UTILITIES
K935103
Evergreen Technologies, Inc.
Radiology · 107d
Cleared Jan 05, 1994
IMPAX 5000
K934386
Heraeus Kulzer, Inc.
Radiology · 119d
Cleared Dec 29, 1993
MAXIVIEW DIAGNOSTIC WORKSTATION
K930500
Dimensional Medicine, Inc.
Radiology · 331d