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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: JAK FDA class 2

    System, X-Ray, Tomography, Computed

    Radiology

    View full classification →

    A computed tomography X-ray system, commonly known as a CT scanner, uses a rotating X-ray source and detector array to acquire cross-sectional images of the body, which are reconstructed by computer into detailed anatomical slices used for diagnosis, treatment planning, and monitoring. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JAK, regulated under 21 CFR 892.1750, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
    Philips iCT CT system
    CT Scanner TSX-501R/1 V11.1
    CardIQ Suite
    SCENARIA View Phase 5.0
    Spectral CT
    uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
    SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
    Vitrea CT VScore
    BodyTom 64
    Brainomix 360 e-Lung
    NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
    Bunkerhill AVC
    uCT 550
    SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
    uCT 780
    syngo.CT Dual Energy
    Aquilion ONE (TSX-308A/3) V1.5
    ClearRead CT CAC
    Gating Reflector Block
    Spectral CT 7500 RT
    CAC (gated) Algorithm
    SOMATOM On.site
    HealthCCSng
    CardIQ Suite
    HiRise (1040-230)
    OmniTom Elite
    Brainomix 360 e-Lung
    CT 5300
    FCT iSTREAM Phase 1
    True Enhance DL
    ABLATE-IQ
    Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
    ECG-less Cardiac
    NAEOTOM Alpha
    SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
    AI-Rad Companion (Pulmonary)
    CAS-One IR
    Revolution Ascend Sliding
    HealthFLD
    Clear Guide SCENERGY
    LungQ v3.0.0
    syngo.CT Applications
    SOMATOM Pro.Pulse
    Aquilion Serve SP (TSX-307B/1) V1.3
    syngo.CT Dual Energy
    uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
    BriefCase-Quantification
    CT Lung Ventilation Analysis Software (CT:V)
    MeVis Liver Suite

    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

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