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510(k) Data Aggregation

    K Number
    K041916
    Device Name
    ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO. LTD USA
    Date Cleared
    2004-07-30

    (14 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALOKA CO. LTD USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial. Modes of operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler. Combined (specify): See Below Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac.
    Device Description
    The Aloka SSD-Alpha 5 Ver. 1.0 diagnostic ultrasound system and transducers. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-Alpha 5 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
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    K Number
    K032875
    Device Name
    ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO. LTD USA
    Date Cleared
    2003-09-30

    (15 days)

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

    ALOKA CO. LTD USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (specify), Intraoperative Neurological, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid.
    Device Description
    The Aloka SSD-5500 V6.0 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-5500 V6.0 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
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