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: IYO FDA class 2

    System, Imaging, Pulsed Echo, Ultrasonic

    Radiology

    View full classification →

    A pulsed echo ultrasonic imaging system uses reflected sound waves to produce real-time cross-sectional images of internal organs and tissues, widely applied in diagnostic imaging across multiple clinical specialties. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) clearance before commercial distribution. The product code is IYO, regulated under 21 CFR 892.1560, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    B-Scan
    Velacur One (LI-1100)
    Accuro 3S
    EchoGuide (Version 1)
    Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
    SpineUs™ System
    Velacur
    SC1 Handheld Ultrasound Imaging system (Model: SC1)
    ACUSON SC2000 Diagnostic Ultrasound System
    B-Ultrasound Diagnostic System
    Pocket III
    EdgeFlow UH10
    BD Prevue™ II Peripheral Vascular Access System
    Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
    Bladder Scanner
    Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
    iSR`obot Mona Lisa 2.0
    K3900 Ultrasound Imaging System
    Velacur
    SiteRite™ 9 Ultrasound System
    Bladder Scanner Model: BVT02
    Velacur
    Butterfly iQ/iQ+ Ultrasound System
    FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
    Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
    QT Scanner 2000 Model A
    Bladder Scanner, Model Name:M5
    NAVIRFA Scope
    ATUSA™ Automated 3D Breast Ultrasound System
    EchoSK and EchoSGyn modules for EchoS Family devices
    iSR’obot Mona Lisa 2.0
    Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
    MD-320W Ultrasound Biomicroscope
    Axialis Ophthalmic Ultrasound System
    Acuson SC2000 Diagnostic Ultrasound System
    FibroScan 230
    SC1 Handheld Ultrasound Imaging System (Model: SC1)
    iSR'obot Mona Lisa 1.0
    BD Prevue II Peripheral Vascular Vascular Access System
    THD Procto Software System
    Palm Bladder Scanner - PBSV7.1
    Breast Volume Navigator (BVN) Model G-2000
    FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
    Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
    IntraSight Mobile
    AcuSee AS-P1000 System
    CUBEScan BioCon-1100
    Liver Incytes, Model 1005
    FibroScan® 630
    Auto 3D Bladder Volume Tool

    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