BEUDAMED
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    BIC TOOL JAPAN

    FDA registration
    BIC TOOL JAPAN·1 product·🇯🇵 Japan

    Aquilion Precision (TSX-304A/4) V10.14 with AiCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion Precision (TSX-304A/4) V10.10 with AiCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion ONE (TSX-305A/6) V8.9 with AiCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kaigen Pharma Co., Ltd.

    Manufacturer
    🇯🇵 Japan

    Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology