BEUDAMED
    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: LMD FDA class 1

    System, Digital Image Communications, Radiological

    Radiology

    View full classification →

    System, Digital Image Communications, Radiological provides electronic transfer of medical image data between medical devices; it may include a physical communications medium, modems, interfaces, and a communications protocol, and may provide simple image review software such as grayscale window and level, zoom and pan, and geometric measurements, but does not perform advanced image processing or complex quantitative functions. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LMD, regulated under 21 CFR 892.2020, within the Radiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    IIVS INTEGRATED IMAGE VIEWING STATION
    STENTOR, PAGEVIEW
    RAYPAX WEB CLINICAL SYSTEM
    ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
    SAMSUNG RAYPAX SYSTEM
    STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
    IMAGEQUEST
    KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
    JPACS
    DOWNSCAN LT
    VR NETSERVE
    BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
    NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE
    IISYS PACS SYSTEM
    VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
    CD-R STATION AND VRS-2000
    KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
    MILTRA IMAGING INC., IMAGE VAULT
    IMAGEACCESS SYSTEM
    BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
    OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
    OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
    ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
    IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
    DICOM 3.0 SOFTWARE VERSION 2.0
    IMATION MODEL 9410 NETWORK INTERFACE
    SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
    MEDSTATION
    IMNET DICOM NETWORK AGENT
    DIGITIZER DIRECTOR (HSC025-01)
    MEDISURF
    MULTIPICS(ME-977)
    SPLITSCREEN (ME-975)
    GE ADVANTAGE DIGITIZER WORKSTATION
    MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
    RIS SCANVIEW SYSTEM (RSVS)
    FREEPIX/PIXPACS DICOM/HTTP GATEWAY
    FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
    AMICAS WEB/INTRANET IMAGE SERVER
    SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
    LINX NETWORKING SYSTEM
    LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
    IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
    IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
    IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
    VIEWSEND MEDICAL MODEL 1200
    AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
    RADWORKS MEDICAL IMAGING SOFTWARE
    INFINET
    SHARED VISION(PART NUMBER SV 0015)

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump