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510(k) Data Aggregation

    K Number
    K070195
    Device Name
    BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
    Date Cleared
    2007-10-15

    (266 days)

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

    BROADSOUND CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The above referenced Broadsound transducer assemblies are intended for use, with standard ultrasound systems, in diagnostic ultrasound imaging or fluid flow analysis of the human body and to be operated by or under the direction of a physician. Their specific indications for use are listed as following: | | Model Name | Specific Indications of Use* | |---|------------|-------------------------------------------------------------| | 1 | AL3C34A | Abdominal, Fetal | | 2 | AL7L50A | Small organ, Peripheral vascular | | 3 | AL3C79B | Abdominal, Fetal, Pediatric | | 4 | AL7L24B | Small organ, Peripheral vascular | | 5 | AT3C42B | Abdominal, Fetal, Pediatric | | 6 | AT3C52B | Abdominal, Fetal, Pediatric | | 7 | AT5L40B | Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal | | 8 | AT3P32A | Abdominal, Adult cephalic, Cardiac | | 9 | AT3P42A | Abdominal, Adult cephalic, Cardiac |
    Device Description
    The above referenced devices are replacement ultrasound transducers used with standard ultrasound systems. Each of them consists of piezoelectric crystals covered with an acoustic lens, a scan head that fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.
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