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510(k) Data Aggregation

    K Number
    K140428
    Device Name
    ULTRASOUND SCANNER SYSTEM BK2300
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2014-05-30

    (100 days)

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

    B-K MEDICAL APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K132335
    Device Name
    ULTRASOUND SCANNER FLEX FOCUS 1202
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2014-01-10

    (168 days)

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

    B-K MEDICAL APS

    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, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ
    Device Description
    Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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 module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.
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    K Number
    K132346
    Device Name
    ULTRASOUND SCANNER PRO FOCUS 2202
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2014-01-10

    (165 days)

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

    B-K MEDICAL APS

    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, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).
    Device Description
    Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can guide biopsy- and puncture needles. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive purpose.
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    K Number
    K132677
    Device Name
    ULTRASOUND SCANNER FLEX FOCUS 1202
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2014-01-07

    (132 days)

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

    B-K MEDICAL APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. 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. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
    Device Description
    Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-mode. CFM mode. Amplitude (Power) Doppler mode 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. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Transducers are linear arrays, convex arrays, phased arrays and mechanical sector.
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    K Number
    K132685
    Device Name
    ULTRASOUND SCANNER PRO FOCUS 2202
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2014-01-06

    (131 days)

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

    B-K MEDICAL APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. 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. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Clinical applications: Ultrasound Scanner Pro Focus 2202: Fetal, Obstetrics, Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Transurethral. Peripheral Vascular, Musculoskeletal. Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic.
    Device Description
    2202 supports the following scanning modes and combinations thereof: B-mode. M-mode. CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging. Contrast harmonic imaging. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. 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. 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 Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
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    K Number
    K123254
    Device Name
    ULTRASOUND SCANNER FLEX FOCUS
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2013-02-13

    (118 days)

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

    B-K MEDICAL APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body. Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. 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. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
    Device Description
    Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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 module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Flex Focus 1202 are Track 3 transducers.
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    K Number
    K100919
    Device Name
    PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2011-12-16

    (623 days)

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

    B-K MEDICAL APS

    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, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial)
    Device Description
    Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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 ECG signal can be superimposed the ultrasound information in all modes and mode combinations. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Pro Focus 2202 are Track 3 transducers.
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    K Number
    K083667
    Device Name
    NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2009-02-02

    (53 days)

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

    B-K MEDICAL APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Needle guide(s) provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures. that require precise needle placement or biopsy.
    Device Description
    The BK Medical Needle Guides described are designed to be used with BK Medical' Ultrasound system to provide alignment with an ultrasound intra-operative transducer, in order to guide a needle (biopsy device, or other interventional device) in relation to the ultrasound image. The components for the Needle Guides are all single use disposable, and delivered sterile. Note! The needle guides are delivered without needles.
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    K Number
    K081323
    Device Name
    BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2008-07-22

    (71 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    B-K MEDICAL APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Performing ultrasound guided biopsies of the prostate
    Device Description
    The biopsy guides are designed to be used with B-K Medical's ultrasound systems to guide needles for taking biopsies of the prostate and similar soft tissue. The biopsy guides are fixed to the ultrasonic probe, and provide a predetermined path for a biopsy needle. The biopsy guides are similar to previously used biopsy guides delivered non sterile. The new biopsy guides are delivered sterile.
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    K Number
    K081154
    Device Name
    ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
    Manufacturer
    B-K MEDICAL APS
    Date Cleared
    2008-05-23

    (30 days)

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

    B-K MEDICAL APS

    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, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
    Device Description
    Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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.
    Ask a Question

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