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510(k) Data Aggregation

    K Number
    K121422
    Device Name
    APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
    Date Cleared
    2012-08-16

    (94 days)

    Product Code
    IYO, ITX, IYN
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).
    Device Description
    The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500. APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 are mobile system. These systems are Track 3 devices that employ a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
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    K Number
    K113466
    Device Name
    AQUILION ONE
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
    Date Cleared
    2012-04-10

    (140 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K112366
    Device Name
    4CH FLEX SPEEDER
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
    Date Cleared
    2011-09-15

    (29 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankie, wrist and elbow), and body (chest, abdomen and pelvis). MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
    Device Description
    The 4ch Flex SPEEDER (MJAJ-192A), is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the human body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions mentioned above. The 4ch Flex SPEEDER (MAJA-192A) consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes. MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
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    K Number
    K110785
    Device Name
    KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
    Date Cleared
    2011-05-27

    (67 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body. image information is obtained for medical diagnosis and treatment.
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    K Number
    K111251
    Device Name
    4CH FLEX SPEEDER
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
    Date Cleared
    2011-05-27

    (23 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)
    Device Description
    The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above. The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.
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