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510(k) Data Aggregation

    K Number
    K223564
    Device Name
    X-CUBE 50, X-CUBE 60
    Date Cleared
    2023-04-17

    (139 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE 50, X-CUBE 60 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF(Pulse Repetition Frequency) Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.
    Device Description
    The X-CUBE 50 and X-CUBE 60 products are general purpose ultrasound imaging system for medical diagnosis assistance. These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device. Also X-CUBE 50 and X-CUBE 60 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices. This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.
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    K Number
    K221093
    Device Name
    X-CUBE 70, X-CUBE 90
    Date Cleared
    2022-10-14

    (184 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE 70 and X-CUBE 90 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic: Adult Cephalic: Trans-raginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph(Cardiac), Peripheral Vessel(PV); and Urology(including prostate). And, the imaging modes are 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode: High PRF Doppler mode: Tissue Doppler Imaging(TDI) Mode: 3D/4D mode. The X-CUBE 70 and X-CUBE 90 are intended to be used in a hospital or medical clinic.
    Device Description
    The X-CUBE 70 and X-CUBE 90 products are general purpose ultrasound imaging system for medical diagnosis assistance. These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device. Also X-CUBE 70 and X-CUBE 90 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices. This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.
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    K Number
    K220857
    Device Name
    X-CUBE 50, X-CUBE 60
    Date Cleared
    2022-10-13

    (204 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE 50, X-CUBE 60 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.
    Device Description
    The X-CUBE 50 and X-CUBE 60 products are general purpose ultrasound imaging system for medical diagnosis assistance. These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device. Also X-CUBE 50 and X-CUBE 60 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices. This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.
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    K Number
    K213523
    Device Name
    X-CUBE i8, X-CUBE i9
    Date Cleared
    2022-01-28

    (86 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE i8, X-CUBE i9 diagnostic ultrasound systems are intended for use by, or by the order the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-raginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode. The X-CUBE i8. X-CUBE i9 are intended to be used in a hospital or medical clinic.
    Device Description
    X-CUBE i8 and X-CUBE i9 products are an ultrasound imaging system for medical diagnosis. This system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality. Signal Mode: 2D(B) mode, Harmonic mode (HAR), M mode, Color M mode, Anatomical M mode, Color Flow Doppler(CF) Mode, Power Doppler(PD) Mode, Directional PD mode, Pulsed Wave Doppler(PWD) Mode, Continuous Wave Doppler(CWD) Mode, High PRF Doppler mode, Tissue Doppler Imaging(TDI) Mode Combination Mode: B/Color Doppler, B/PWD, B/Color Doppler/PWD Acoustic output track: Track 3
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    K Number
    K211299
    Device Name
    X-CUBE 70
    Date Cleared
    2021-08-09

    (103 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 70 is intended to be used in a hospital or medical clinic.
    Device Description
    X-CUBE 70 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
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    K Number
    K211300
    Device Name
    X-CUBE 90
    Date Cleared
    2021-08-09

    (103 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE 90 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 90 is intended to be used in a hospital or medical clinic.
    Device Description
    X-CUBE 90 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
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    K Number
    K200449
    Device Name
    X-Cube 90
    Date Cleared
    2020-07-10

    (137 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE 90 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harnonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 90 is intended to be used in a hospital or medical clinic.
    Device Description
    X-CUBE 90 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
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    K Number
    K200450
    Device Name
    X-Cube 70
    Date Cleared
    2020-07-10

    (137 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal: Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode: 3D/4D mode. The X-CUBE 70 is intended to be used in a hospital or medical clinic.
    Device Description
    X-CUBE 70 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
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    K Number
    K182594
    Device Name
    E-CUBE i7
    Date Cleared
    2019-01-24

    (126 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
    Device Description
    E-CUBE i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable(only body) and mobile(with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality. 1. Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode, 3D, 4D B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M
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    K Number
    K182845
    Device Name
    minisono
    Date Cleared
    2018-12-27

    (79 days)

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

    Alpinion Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
    Device Description
    minisono product is an ultrasound imaging system for medical diagnosis. This device is available for portable and tablet PC (Microsoft corp., Surface pro). Also, this innovative system platform provides optimal patient diagnosis workflow with the tablet PC, optimal image quality. 1. Signal Mode: B(2D) mode, M mode, Pulsed Wave Doppler(PWD) mode, Color Doppler, Power Doppler, Tissue Harmonic Imaging 2. Combination Mode: B/Color Doppler, B/PWD, B/Color Doppler/PWD
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