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    GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover for Hino, OPTIMA CT540 TANG, OPTIMA CT540 TANG BEIJING, OPTIMA CT540 TANG HINO

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    Allm Inc.

    Manufacturer
    🇯🇵 Japan

    ST AIA-PACK CEA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

    AIA-PACK CEA CALIBRATOR SET

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

    CL AIA-PACK CEA ADJUSTER SET

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

    CL AIA-PACK CEA TEST CUP

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

    AIA-PACK CEA SAMPLE DILUTING SOLUTION

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device