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510(k) Data Aggregation

    K Number
    K111227
    Device Name
    ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2011-05-13

    (11 days)

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

    ALOKA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
    Device Description
    The SSD-3500 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
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    K Number
    K110207
    Device Name
    ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2011-02-17

    (23 days)

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

    ALOKA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal , Trans-rectal, Gynecological, Musculo-sketal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
    Device Description
    The Prosound F75 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
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    K Number
    K093488
    Device Name
    ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2009-11-20

    (10 days)

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

    ALOKA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of the Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Transvaginal , Trans-rectal, Gynecological and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Transrectal, Transvaginal, Fetal, Abdominal, Gynecological, Cardiac, Peripheral Vascular, Small Organ, Intra-operative, Neonatal Cephalic.
    Device Description
    The Prosound Alpha 6 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
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    K Number
    K083254
    Device Name
    ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2008-12-19

    (45 days)

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

    ALOKA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications.
    Device Description
    The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing. The user interface includes a computer type keyboard. specialized controls and a display.
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    K Number
    K081843
    Device Name
    ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2008-07-15

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALOKA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.
    Device Description
    The Aloka DAS-RS1 system is a software based medical image system. This system receives, reviews and store patient exam images and data, prepare/print reports and communicates with Aloka Ultrasound systems. This system has a PC workstation that can be used to analyze the data for report generation. The software allows for the download of DICOM files to a single PC from a single Aloka Ultrasound system located within the same facility.
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    K Number
    K080176
    Device Name
    ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2008-02-29

    (36 days)

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

    ALOKA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Peripheral Vascular, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular) applications. The device is not indicated for Ophthalmic applications.
    Device Description
    The Aloka Prosound 6 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a video display.
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    K Number
    K072285
    Device Name
    ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2007-08-30

    (14 days)

    Product Code
    ITX, IYN, IYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALOKA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo- skeletal Conventional, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular). The device is not indicated for ophthalmic applications.
    Device Description
    The Aloka SSD-Alpha 7 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a video display. This configuration will provide user enhancements and expanded use.
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    K Number
    K060059
    Device Name
    ALOKA SD-3500 ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2006-01-13

    (4 days)

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

    ALOKA CO., LTD.

    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, M/CD, B/CD/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.
    Device Description
    The Aloka SSD-3500 Ver. 7.0 diagnostic ultrasound system and transducers. High frequency sound waves are transmitted into the body by a piezoelectric 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-3500 Ver. 7.0 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
    K043196
    Device Name
    ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2004-11-30

    (12 days)

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

    ALOKA CO., LTD.

    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 (liver/pancreas/gall-bladder/abdominal, gynecological, fetal, neonatal, cardiac), Pediatric, Small Organ (breast/testes/thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional. Mixed mode operation includes BM, BPWD, MCD, BICD/PWD, BICWD, BICWCWD.
    Device Description
    The Aloka SSD-Alpha 10 functions in the same manner as its predicate and other Aloka 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-Alpha 10 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
    K040719
    Device Name
    ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
    Manufacturer
    ALOKA CO., LTD.
    Date Cleared
    2004-03-26

    (7 days)

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

    ALOKA CO., LTD.

    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 (liver, pancreas, and gall bladder), Intraoperative Neurological, Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
    Device Description
    The Aloka SSD-4000 Ver.3.1 functions in the same manner as its predicates and 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-4000 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow. The SONOReal accessory (K023473) is an add on device.
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