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: JAD FDA class 2

    System, Therapeutic, X-Ray

    Radiology

    View full classification →

    A therapeutic X-ray system is used in radiation therapy to deliver controlled doses of X-ray radiation for the treatment of malignant and benign tumors and other conditions, encompassing the full range of voltage configurations used in external beam radiotherapy. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before commercial distribution. The product code is JAD, regulated under 21 CFR 892.5900, within the Radiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
    X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
    Esteya
    Sensus Healthcare TVM Balloon Applicator
    Sensus IORT System
    SRT-100+
    Photoelectric Therapy System
    INTRABEAM 600
    Axxent Electronic Brachytherapy System Model 110 XP 1200
    Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
    AXXENT CERVICAL APPLICATOR
    ESTEYA
    SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
    INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
    SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
    XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
    INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
    INTRABEAM NEEDLE APPLICATOR
    AXXENT RADIATION SHIELD - RIGID
    INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
    AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
    AXXENT SURFACE APPLICATOR, MODEL 710257
    AXXENT VAGINAL APPLICATOR
    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
    SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
    INTRABEAM SYSTEM
    PHOTON RADIOSURGERY SYSTEM (PRS)
    PHOTON RADIOSURGERY SYSTEM PRS400
    THERAPAX DXT 300 MODEL HF-300
    VERIDOSE V (FIVE), MODEL NUMBER 37-705
    PHOTON RADIOSURGERY SYSTEM (PRS)
    THERAPAX SXT 150
    DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
    INSTA-FLO
    THERAPAX DXT 300 SERIES 3
    HUESTIS FLEXI-BOARD
    COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
    FABFOAM #302
    CMS RECORD AND VERIFY SYSTEM
    S9 DISPLAY SYSTEM
    PLAN-32 SOFTWARE
    THERAPAX HT 150T
    MEVAMATIC 3
    INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
    RTP-5100-5200-5300 & 5400
    RTP-5000
    RADIATION BOLUS
    THERAPAX 150A
    RADIATION THERAPY TREAT. PLAN. SYS.

    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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