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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: MQB FDA class 2

    Solid State X-Ray Imager (Flat Panel/Digital Imager)

    Radiology

    View full classification →

    The Solid State X-Ray Imager (Flat Panel/Digital Imager) is a radiology device that uses solid-state detector technology to convert X-ray energy directly into digital images, replacing traditional film or image intensifiers and providing high-quality digital radiographic images. Classified as FDA Class 2 under 21 CFR 892.1680, it requires 510(k) premarket notification. The product code is MQB, and it is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SKR 3000
    Wireless/ Wired X-Ray Flat Panel Detectors
    EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
    EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
    Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
    ExamVue Apex
    Yushan X-Ray Flat Panel Detector
    SKR 3000
    VIVIX-S 1751S
    PRORAD X-Ray Flat Panel Detector with DROC
    IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
    Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
    0909FCC, 0909FCC-HS
    EXPD 4343S
    EXPD 4343D; EXPD 3643D
    MasterX 800 Series
    YosemiteView 4343W/YosemiteView 3643W
    EXPD 4357; EXPD 4357P
    AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
    1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
    A1417MCW/A1717MCW/F1417MCW
    Digital Radiography CXDI-CS01
    Digital Flat Panel Detector
    14HQ721G-B
    X-ray Flat Panel Detectors (EverestView 4343X)
    Wireless/Wired X-Ray Flat Panel Detectors
    EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
    SKR 3000
    Mercu 1717V
    Digital Radiography CXDI-Pro, Digital Radiography D1
    Digital Radiography CXDI-Elite, Digital Radiography E1
    Digital Radiography CXDI-CS01
    Solid State X-ray Imager(Model: FXRD-4386WB)
    X-ray Flat Panel Detectors (CareView 1800 RF)
    10HQ701G-B
    14HQ701G-B
    Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
    Digital Radiography CXDI-Pro, Digital Radiography D1
    17HQ701G-B
    Flat Panel Detector
    Wireless Digital Flat Panel Detector
    Digital Radiography CXDI-Elite, Digital Radiography E1
    PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
    17HQ901G-B
    Digital flat panel detector
    Yushan X-Ray Flat Panel Detector with DROC
    Wireless Digital Flat Panel Detector
    Focus HD 43 Detector
    Focus HD 35 Detector
    14HQ901G-B

    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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