LMD — System, Digital Image Communications, Radiological Class I

FDA Device Classification

Classification Details

Product Code
LMD
Device Class
Class I
Regulation Number
892.2020
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K994329terareconIIVS INTEGRATED IMAGE VIEWING STATIONMay 26, 2000
K992698stentorSTENTOR, PAGEVIEWOctober 25, 1999
K992426samsung sds coRAYPAX WEB CLINICAL SYSTEMOctober 13, 1999
K992352inteleradiologyITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0September 29, 1999
K991537samsung sds coSAMSUNG RAYPAX SYSTEMJuly 6, 1999
K984000surgical navigation technologiesSTEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMJanuary 12, 1999
K974707visual medIMAGEQUESTJuly 31, 1998
K981053eastman kodakKODAK DIGITAL SCIENCES (KDS) IMAGE VIEWJune 18, 1998
K980918philips medical systems (cleveland)JPACSJune 3, 1998
K974882merlin engineering worksDOWNSCAN LTMay 22, 1998
K980684i.s.g. technologiesVR NETSERVEMay 6, 1998
K980541barco nv display systemsBARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAYApril 9, 1998
K980241netco communicationsNETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWAREMarch 17, 1998
K980220sterling diagnostic imagingIISYS PACS SYSTEMFebruary 13, 1998
K974130dejarnette research systemsVISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWAREJanuary 29, 1998
K974255electromed intlCD-R STATION AND VRS-2000January 27, 1998
K974107eastman kodakKODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)January 21, 1998
K974102mitra imagingMILTRA IMAGING INC., IMAGE VAULTJanuary 20, 1998
K972701barco nv display systemsBARCO MWD 321 MEDICAL WORKSTATION DISPLAYJanuary 2, 1998
K973805storcommIMAGEACCESS SYSTEMJanuary 2, 1998