BEUDAMED
    Product Code: MWP FDA class 2 21 CFR 892.1680

    Cabinet, X-Ray System

    Radiology

    A Cabinet X-Ray System is a radiation-emitting device that uses X-rays for inspection, analysis, or screening purposes within a fully shielded enclosure, used in industrial, security, or laboratory settings rather than for direct medical imaging of patients. It is FDA Class 2, requiring 510(k) clearance, with product code MWP under 21 CFR 892.1680 in the Radiology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    27
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    12
    Years Active
    38

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    Basic Information

    Product Code
    MWP
    Device Class
    FDA class 2
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 27 510(k) clearances via K numbers.

    K Number Device Name
    K230140 TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
    K230136 TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
    K213691 Solas OR
    K210955 Kubtec Mozart Supra (XPERT 84) Radiography System
    K210957 Kubec Xpert 80 Radiography System
    K210956 Kubtec Mozart (XPERT42)
    K202713 TrueView 100 Pro
    K200756 Kubtec Mozart Supra
    K192939 Volumetric Specimen Imager
    K193317 CoreLite X-Ray Specimen Cabinet
    K183624 Kubtec Mozart (Xpert42)
    K183142 PathVisionXL
    K182727 Trident HD Specimen Radiography System
    K173309 Faxitron VisionCT
    K170786 Faxitron Bioptics Speciemen Radiography System
    K153583 BioVision Plus
    K122428 FAXITRON SPECIEN RADIOGRAPHY SYSTEM
    K111508 TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
    K091928 10 X 10 VISION
    K091558 BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
    K082432 CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
    K072557 FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20
    K071233 XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
    K061361 FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
    K052433 PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
    K021113 MAMMOPATH
    K852634 MICRO-FOCUS 50 CABINET X-RAY

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.