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    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: LMB FDA class 1

    Device, Digital Image Storage, Radiological

    Radiology

    View full classification →

    Device, Digital Image Storage, Radiological provides electronic maintenance and access functions for medical images, serving as hardware-based storage infrastructure within a medical imaging system such as a PACS (Picture Archiving and Communication System). This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LMB, regulated under 21 CFR 892.2010, within the Radiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SAMSUNG RAYPAX LONG TERM ARCHIVE
    ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
    WISE (II) IMAGE MANAGEMENT SYSTEM
    PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
    OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
    ID. STORE (RELEASE 2.0)
    KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
    TDK MEDICAL GRADE CD-R
    WISE IMAGE MANAGEMENT SYSTEM
    ACCESSPOINT, MED E-MAIL, DICOM READER
    UNIVISION ECHOCARDIOLOGY SYSTEM
    WRITESTAR, AND VIEWSTAR
    IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
    SONY DKR-700 DIGITAL STILL RECORDER
    UPACS VERSION 1.7
    KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
    UPACS
    LAST IMAGE HOLD
    TIGERSCAN/TIGERVIEW
    FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM
    VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)
    ACCULUPE
    NT SERIES DIGITAL IMAGE MANAGER
    WALLACH DIGITAL IMAGING SYSTEM
    OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
    TOMTECP90
    INSTACINE
    STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER
    NICOM DIGITAL IMAGE MANAGER
    DIGITAL DISK RECORDER
    7500 DATA TOWER
    NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM
    OLYMPUS IMAGEMANAGER SYSTEM
    OLYMPUS IMAGEMANAGERSYSTEM
    SC1000 SCAN CONVERTER
    ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM
    SONY LASER VIDEODISC RECORDING SYSTEM
    KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
    VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM
    DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
    ANGIOTEC IMAGE MANAGEMENT SYSTEM
    DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
    OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
    KODAK EKTASCAN IMAGE MANAGER
    PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
    ANGIOTEC FMX-2220 SYSTEM
    IMS-3 PICTURE ARCHIVING SYSTEM
    DISKCAM DC 6001
    HR-1000 W/SUFFIXES (B,C OR D)
    KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET

    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.

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