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

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

142 devices
1–24 of 142
Cleared May 26, 2000
IIVS INTEGRATED IMAGE VIEWING STATION
K994329
Terarecon,Inc.
Radiology · 156d
Cleared Oct 25, 1999
STENTOR, PAGEVIEW
K992698
Stentor, Inc.
Radiology · 75d
Cleared Oct 13, 1999
RAYPAX WEB CLINICAL SYSTEM
K992426
Samsung Sds Co., Ltd.
Radiology · 84d
Cleared Sep 29, 1999
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
K992352
Inteleradiology, Inc.
Radiology · 77d
Cleared Jul 06, 1999
SAMSUNG RAYPAX SYSTEM
K991537
Samsung Sds Co., Ltd.
Radiology · 64d
Cleared Jan 12, 1999
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
K984000
Surgical Navigation Technologies, Inc.
Radiology · 63d
Cleared Jul 31, 1998
IMAGEQUEST
K974707
Visual Med, Inc.
Radiology · 227d
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 May 22, 1998
DOWNSCAN LT
K974882
Merlin Engineering Works, Inc.
Radiology · 143d
Cleared May 06, 1998
VR NETSERVE
K980684
I.S.G. Technologies, Inc.
Radiology · 72d
Cleared Apr 09, 1998
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
K980541
Barco NV Display Systems
Radiology · 57d
Cleared Mar 17, 1998
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE
K980241
Netco Communications Corp.
Radiology · 53d
Cleared Feb 13, 1998
IISYS PACS SYSTEM
K980220
Sterling Diagnostic Imaging, Inc.
Radiology · 22d
Cleared Jan 29, 1998
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
K974130
Dejarnette Research Systems
Radiology · 87d
Cleared Jan 27, 1998
CD-R STATION AND VRS-2000
K974255
Electromed Intl., Ltd.
Radiology · 75d
Cleared Jan 21, 1998
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
K974107
Eastman Kodak Company
Radiology · 82d
Cleared Jan 20, 1998
MILTRA IMAGING INC., IMAGE VAULT
K974102
Mitra Imaging, Inc.
Radiology · 81d
Cleared Jan 02, 1998
BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
K972701
Barco NV Display Systems
Radiology · 168d
Cleared Jan 02, 1998
IMAGEACCESS SYSTEM
K973805
Storcomm, Inc.
Radiology · 88d
Cleared Dec 22, 1997
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
K973959
Olicon Imaging Systems, Inc.
Radiology · 67d
Cleared Dec 17, 1997
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
K973793
Olicon Imaging Systems, Inc.
Radiology · 72d
Cleared Dec 05, 1997
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
K972925
Access Radiology Corp.
Radiology · 119d
Cleared Dec 05, 1997
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
K973421
Dejarnette Research Systems
Radiology · 86d

About Product Code LMD - Regulatory Context