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510(k) Data Aggregation

    K Number
    K043554
    Device Name
    ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
    Manufacturer
    B-K MEDICAL A/S
    Date Cleared
    2005-01-14

    (18 days)

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

    B-K MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal, Intraoperative, Pediatrics, Transrectal, Small Parts (organ), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).
    Device Description
    Mini Focus 1402 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. B mode includes tissue harmonic imaging. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. The system can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. (Freehand tracking). Transducers are linear and convex arrays and mechanical sector.
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    K Number
    K043524
    Device Name
    ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
    Manufacturer
    B-K MEDICAL A/S
    Date Cleared
    2005-01-13

    (24 days)

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

    B-K MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
    Device Description
    Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
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    K Number
    K024236
    Device Name
    ULTRASOUND SCANNER, TYPE 2400
    Manufacturer
    B-K MEDICAL A/S
    Date Cleared
    2003-01-17

    (25 days)

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

    B-K MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal Doppler, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Musculo-skeletal.
    Device Description
    2400 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode and CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 2400 are Track 3 transducers.
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    K Number
    K023457
    Device Name
    ULTRASOUND SCANNER, TYPE 1101
    Manufacturer
    B-K MEDICAL A/S
    Date Cleared
    2002-11-01

    (17 days)

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

    B-K MEDICAL A/S

    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, Intraoperative Neurological, Pediatrics, Small Organ, Cardiac, Transrectal, Transvaginal, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
    Device Description
    1101 supports the following scanning modes and combinations thereof: B-mode M-mode. The system can perform simple geometric measurements, and perform calculations in the areas of Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 1101 are Track 3 transducers.
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    K Number
    K011417
    Device Name
    ULTRASOUND SCANNER, TYPE 2102
    Manufacturer
    B-K MEDICAL A/S
    Date Cleared
    2001-06-08

    (30 days)

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

    B-K MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003986
    Device Name
    ULTRASOUND SCANNER TYPE 2102
    Manufacturer
    B-K MEDICAL A/S
    Date Cleared
    2001-04-03

    (98 days)

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

    B-K MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003041
    Device Name
    ULTRASOUND SCANNER TYPE 2101
    Manufacturer
    B-K MEDICAL A/S
    Date Cleared
    2001-02-07

    (131 days)

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

    B-K MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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