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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: IXR FDA class 2

    Table, Radiographic, Tilting

    Radiology

    View full classification →

    A tilting radiographic table is a patient support table capable of rotating from horizontal to vertical positions, used to perform radiographic examinations requiring changes in patient orientation, such as barium swallow studies and fluoroscopic evaluations. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXR, regulated under 21 CFR 892.1980, within the Radiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VISION R/F TILTING TABLE
    LEGACY/LEGACY-D TABLE
    CAP-35B III/CINE 275
    PHILIPS EASY DIAGNOST
    ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
    FLUOROVIEW SERIES FLUOROSCOPIC TABLES
    TILTING RADIOGRAPHIC TABLE (REMOTE)
    TANGENT VI TABLE
    COMPAX 90/15E
    SURGICAL C-ARM TABLE, 9610
    VACS TABLE, 9650
    KOORDINAT M
    ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
    CORSINI 9090
    MOBILIX MOBILE X-RAY TABLE
    HYDRADJUST IV UROLOGICAL TABLE
    URO - ELITE TABLE ACCESSORIES
    OCTOSTOP(R) CHAIR (NEW MODEL
    CLINIX VP 4 TABLE
    MODEL MPFT-01, GENESIS
    SPECTRUM MARK I SPECIAL PROCEDURES TABLE
    ARTHRODYN 45 DEGREE X-RAY TABLE
    SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
    UROLOGICAL C-ARM TABLE, MODEL #056-450
    DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
    UROLOGICAL X-RAY TABLE HS-10A
    X-RAY DIAGNOSTIC TABLE YSF-100
    HYDRAJUST IV UROLOGICAL TABLE
    X-RAY DIAGNOSTIC TABLE YSF-200-30-90
    MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE
    MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE
    TANGENT V
    X-RAY TABLE
    ELITE R 90/15
    SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
    TREATMENT TABLE
    TANGENT IV
    PHILIPS URO DIAGNOST MRF
    RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
    620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
    ELITE 5000
    REMOTE CONTROLLED X-RAY DIAG. RSZ-200
    REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
    MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
    G.E. MONITROL 90 AND G.E. MONITROL 15
    MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
    UROMAT 2000
    F.A.S.T. TABLE
    RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
    ELITE 1500 RADIOGRAPHIC TILTING TABLE

    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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