Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K243226
    Device Name
    Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
    Manufacturer
    Date Cleared
    2025-05-08

    (212 days)

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

    Leltek Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: **LX Series:** Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve **128 Series:** Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve **LU700 Series:** Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
    Device Description
    The Ultrasound Imaging System is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device. I. The imaging system software runs as an app on a mobile device. II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface. III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device. IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components A complete list of all the probes and indications including: Dual headed probe **LX Series:** **LX128LC** **Linear transducer:** Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **Convex transducer:** Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve **LX128LP** **Linear transducer:** Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **Phased Array transducer:** ,Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve **LX192LC** **Linear transducer:** Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superf-dotorial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **Convex transducer:** ,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve Single headed probe **128 Series:** **LK128C** Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve **LK128L** Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **LK128LH** Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **LK128M** Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) **LK128PA** Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve **LK128E** Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter) **LU700 Series:** **LU700L** General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **LU710L** Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **LU710LH** Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve **LU700C** General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve **LU710C** Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve **LU710M** Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) **LU710PA** Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve **LU710E** Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)
    Ask a Question

    Ask a specific question about this device

    K Number
    K241161
    Device Name
    Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging
    Manufacturer
    Date Cleared
    2024-09-11

    (138 days)

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

    Leltek Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultrasound Imaging System (Model: 128 Series) and (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD) Specific clinical applications and exam types including: LK128C Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac (adult), Cardiac (pediatric).Peripheral vessel .interventional quidance (free hand needle/ catheter).FAST/ EFAST,Nerve LK128L Ophthalmic General abdominal imaging Pediatric, Small organ (thyroid, prostate, scrotum, breast).Neonatal cephalic.Musculoskeletal (conventional).Musculoskeletal (superficial).Peripheral vessel , Other (Carotid), Pulmonary, interventional guidance (free hand needle/ catheter), Nerve LK128LH Ophthalmic General abdominal imaging Pediatric, Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel , Other (Carotid), Pulmonary, interventional guidance (free hand needle/ catheter), Nerve LK128M Fetal General abdominal imaging Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel interventional guidance (free hand needle/ catheter) LK128PA Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary, FAST/ EFAST,Nerve LK128E Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Trans-rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance (free hand needle/ catheter) LU700L General abdominal imaging Pediatric, Small organ (thyroid, prostate, scrotum, breast).Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial).Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve LU710L Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel , Other (Carotid), Pulmonary, interventional guidance (free hand needle/ catheter), Nerve LU710LH Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel . Other (Carotid),Pulmonary.interventional quidance (free hand needle/ catheter),Nerve LU700C General abdominal imaging, Musculoskeletal (conventional), Musculoskeletal (superficial), OB/ Gyn, Peripheral vessel .interventional guidance (free hand needlel catheter),FAST/EFAST,Nerve LU710C Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast).Urology.Musculoskeletal (conventional).OB/Gyn.Cardiac (adult).Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/ EFAST,Nerve LU710M Fetal General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic.Urology.Musculoskeletal (conventional).OB/Gvn.Cardiac (adult).Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710PA Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/ EFAST.Nerve LU710E Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Trans-rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance (free hand needle/ catheter)
    Device Description
    The Ultrasound Imaging System is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.. - I. The imaging system software runs as an app on a mobile device. - II. The imaging system software can be download to a commercial off-the-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface. - III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device. - IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
    Ask a Question

    Ask a specific question about this device

    K Number
    K222365
    Device Name
    Leltek Ultrasound Imaging System (Model: LU700 Series)
    Manufacturer
    Date Cleared
    2022-10-25

    (82 days)

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

    Leltek Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: LU700L General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional),Musculosketal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter) LU710L Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic.Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter) LU710LH Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter) LU700C General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710C Fetal.General abdominal imaging.Small organ (thyroid, prostate, scrotum, breast).Urology.Musculoskeletal (conventional),OB/Gyn,Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710M Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic. Urology. Musculoskeletal (conventional), OB/Gyn. Cardiac (pediatric), Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710PA Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary LU710E Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Transvaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter) The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients.
    Device Description
    The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device. - I. The imaging system software runs as an app on a mobile device. - II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface. - III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device. - IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
    Ask a Question

    Ask a specific question about this device

    K Number
    K210432
    Device Name
    LELTEK Ultrasound Imaging System (Model: LU700 Series)
    Manufacturer
    Date Cleared
    2021-11-03

    (264 days)

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

    Leltek Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: LU700C General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel. LU710C Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710M Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710PA Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric. LU710E Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology.
    Device Description
    The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device. - l. The imaging system software runs as an app on a mobile device. - II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface. - III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device. - IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
    Ask a Question

    Ask a specific question about this device

    K Number
    K191235
    Device Name
    Leltek Ultrasound Imaging System
    Manufacturer
    Date Cleared
    2020-02-12

    (280 days)

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

    Leltek Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Leltek Ultrasound Imaging System (Model: LU700) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft. Specific clinical applications and exam types including: For LU700C: General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/ Gyn. The modes of operation include B mode. M mode. PWD mode, Color Doppler (CD) mode. Power Doppler mode. and the combined mode(B+M, B+CD, B+PWD). For LU700L: General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. The modes of operation includes B mode, M mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode(B+M, B+CD, B+PWD).
    Device Description
    The Leltek Ultrasound Imaging System is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) Android mobile device. l. The imaging system software runs as an app on a mobile device. II. The imaging system software can be download to a commercial off-the-shelf (COTS) Android mobile device and utilizes an icon touch-based user interface. lll. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device. IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1