BEUDAMED
    Product Code: QKB FDA class 2 21 CFR 892.2050

    Radiological Image Processing Software For Radiation Therapy

    Radiology

    Radiological Image Processing Software For Radiation Therapy is a Class 2 radiology software device that uses artificial intelligence, including nonadaptive machine learning algorithms, to provide semi-automatic or fully-automated radiological image processing and analysis tools in radiation therapy workflows; primary radiation dose calculation or plan optimization is explicitly outside its scope. It requires 510(k) clearance and is regulated under 21 CFR 892.2050 within the Radiology medical specialty. The product code is QKB. The device is not an implant and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    46
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    27
    Years Active
    8

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    Basic Information

    Product Code
    QKB
    Device Class
    FDA class 2
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

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

    Definition

    To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 46 510(k) clearances via K numbers.

    K Number Device Name
    K252548 AI-Rad Companion Organs RT
    K252190 DeepBT Detector-Plus
    K253270 Contour ProtégéAI+
    K260509 AutoContour (RADAC V5)
    K251306 Seg Pro V3 (RT-300)
    K251351 AccuContour 4.0
    K250780 ARTAssistant
    K250427 TAIMedImg DeepMets
    K242925 MR Contour DL
    K242745 AI-Rad Companion Organs RT
    K242994 OncoStudio (OS-01)
    K250035 Contour ProtégéAI+
    K242729 AutoContour (Model RADAC V4)
    K241490 Contour+ (MVision AI Segmentation)
    K241837 Limbus Contour
    K232928 DeepContour (V1.0)
    K232899 AI-Rad Companion Organs RT
    K231855 QOCA® image Smart RT Contouring System
    K231765 Contour ProtégéAI
    K231928 EFAI RTSUITE CT HCAP-Segmentation System
    K230082 Auto Segmentation
    K230023 ART-Plan
    K230685 AutoContour Model RADAC V3
    K223774 Contour ProtégéAI
    K221706 AccuContour
    K220408 AVIEW RT ACS
    K221305 AI-Rad Companion Organs RT
    K220598 AutoContour Model RADAC V2
    K220813 ART-PLAN
    K212915 MVision AI Segmentation
    K220264 EFAI RTSuite CT HN-Segmentation System
    K213976 Contour ProtégéAI
    K213628 VBrain
    K213155 RT-Mind-AI
    K212218 Advanced Algorithms for Treatment Management Applications (AATMA)
    K210632 Contour ProtegeAI
    K212116 VBrain-OAR
    K203610 Automatic Anatomy Recognition (AAR)
    K202928 DV. Target
    K203235 VBrain
    K202700 ART-Plan
    K193562 AI-Rad Companion Organs RT
    K200323 AutoContour
    K193252 Contour ProtegeAI
    K191928 AccuContour
    K181572 Workflow Box

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.