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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: IYX FDA class 1

    Camera, Scintillation (Gamma)

    Radiology

    View full classification →

    A gamma scintillation camera, also known as an Anger camera, detects gamma rays emitted from radionuclides administered to patients and creates planar scintigraphic images used to evaluate organ function and identify disease. It is classified as FDA Class 1, reflecting minimal regulatory burden with only general controls required and no premarket notification. The product code is IYX, regulated under 21 CFR 892.1100, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
    3D-RD-S
    OLINDA EXM
    Discovery NM 750b Bopsy
    Sentinella 102, Sentinella 102 Horus
    Sentinella 102; Sentinella 102 Horus
    ERGO IMAGING SYSTEM
    LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
    DILON 6800 ACELLA (ACELLA)
    SENTINELLA 102
    DISCOVERY NM 750B
    SCANDIA-45 GAMMA CAMERA SYSTEM
    ERGO IMAGING SYSTEM
    PROXISCAN MODEL 101
    GAMMALOC SYSTEM, MODEL 03-00001
    MODEL SENTINELLA 102
    VERISTA IMAGING ISOCAM II GAMMA CAMERA
    CAPIMAGE
    T-QUEST SYSTEM
    KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
    MAMMOPAD RADIOLUCENT CUSHION
    CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
    ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
    OLINDA/EXM
    MINI GAMMA CAMERA, MODEL MGC-500
    ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
    EZ-SCOPE AN, EZ-SCOPE LIGHT
    EZ-SCOPE AN & EZ-SCOPE AN LITE
    PORTABLE BREAST COMPRESSION DEVICE
    LUMAGEM SCINTILLATION CAMERA
    DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
    NOTEBOOK IMAGER
    IM512P
    DI-2000
    VISION FX 40 & 80 SERIES GAMMA CAMERA
    CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS
    APEX SPX CARDIAL
    CARBON FIBER PALLET
    R &D BATTERIES, INC. PART # 5015, 5192, 5482
    FAN BEAM COLLIMATOR
    QUANTEM (TM)
    SPECTURN, MODEL TTK-128
    THYRUS
    UNIX-LINK
    NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES
    NEW DETECTOR FOR TRANSCAM/POLARIS S315
    NEW DETECTOR OPTION
    MEDX ROTATIONAL GANTRY SYSTEM
    ADAC S315
    NEUROCAM

    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