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510(k) Data Aggregation

    K Number
    K250762
    Device Name
    ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-07-11

    (120 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250524
    Device Name
    Mendaera Guidance System
    Manufacturer
    Mendaera, Inc.
    Date Cleared
    2025-07-02

    (131 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250469
    Device Name
    Accuro® 3S Needle Guide Kit
    Manufacturer
    Rivanna Medical, Inc.
    Date Cleared
    2025-06-13

    (115 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accuro® 3S Needle Guide Kit is intended to be used with the Accuro® 3S diagnostic ultrasound imaging system. The Accuro® 3S Needle Guide Kit supports alignment of a needle with the ultrasound imaging plane to assist the healthcare professional in placing the tip of a needle relative to a specific anatomical structure. The elastic bands on the Patient Drape are intended to stabilize the positioning of the Accuro® 3S Needle Guide. The Accuro® 3S Probe Cover sheathes the transducer and isolates a needle insertion site from microbial and other contaminants.
    Device Description
    The Accuro® 3S Needle Guide Kit consists of the following single use sterile disposable components: Accuro® 3S Needle Guide with integrated probe cover, conductive ultrasound gel, and a patient drape with two integrated probe elastic bands. The kit components are assembled into a sterilized CSR Wrap then packaged in a sterile tray. The final kit is sterilized under ethylene oxide.
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    K Number
    K241662
    Device Name
    Ultrasound Transducer Cover
    Manufacturer
    Vitrolife Sweden AB
    Date Cleared
    2024-08-30

    (81 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.
    Device Description
    The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans. The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.
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    K Number
    K233965
    Device Name
    UltraDrape UGPIV Barrier and Securement (34-15)
    Manufacturer
    Parker Laboratories, Inc.
    Date Cleared
    2024-08-15

    (244 days)

    Product Code
    ITX, KGX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraDrape UGPIV Barrier and Securement, a sterile, single-use disposable device, serves as a sterile, viral barrier when used in conjunction with ultrasound transducers to shield patients from the potential transfer of contaminants and biological risk agents that may be introduced during ultrasound scanning and needle-quided procedures. It also serves as a transparent dressing to protect and secure devices to the patient's skin when required. UltraDrape UGPIV Barrier and Securement is indicated for adults and pediatric patients. For use by healthcare professionals appropriately trained in ultrasound within healthcare settings utilizing ultrasound.
    Device Description
    UltraDrape UGPIV Barrier and Securement is a uniquely designed, sterile, dual-action barrier and securement dressing designed for use during Ultrasound-Guided Peripheral Intravenous (UGPIV) procedures. UltraDrape is 3.25"(8.25 cm) wide x 5.8" (14.72 cm) long. UltraDrape UGPIV Barrier and Securement is sterile, nonirritating, non-sensitizing and is not made with natural rubber latex. Ultrasound imaging is not impaired by use of UltraDrape UGPIV Barrier and Securement as it is intended. The ultrasound gel is applied to a removable Polyurethane film layer to prevent contamination of the injection site. Convenient adhesive strips on the release film provide added securement of tubing and catheter hub surround. The bifurcated, "stand-alone" design prevents gel from reaching the IV site while enabling seamless catheter insertion and securement. UltraDrape UGPIV Barrier and Securement is furnished in sterile condition, for single use patient/procedure use, disposable. UltraDrape UGPIV Barrier and Securement is used with commercially available ultrasound probes.
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    K Number
    K241615
    Device Name
    Transducer Probe Cover
    Manufacturer
    Hony Medical Co., Ltd.
    Date Cleared
    2024-07-03

    (28 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.
    Device Description
    The subject device is composed of transparent thin-walled polyurethane sleeve, rubber ring and (or) tape strip. A conventional 0.05mm thin, 49 GSM (Grams per Square Meter), transparent high strength polyurethane film tube shape, in various dimensions with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for body surface, endocavity and intra-operative diagnostic ultrasound. This may help with easier cleaning and disinfection of the probe. Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required. The Transducer Probe Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary the removal process is accomplished by pulling the cover off the transducer in a reverse method from the application. The subject device is furnished in sterile condition, for single use patient/procedure use, disposable. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
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    K Number
    K233109
    Device Name
    TP Pivot Pro™ Needle Guide
    Manufacturer
    CIVCO Medical Solutions
    Date Cleared
    2023-12-22

    (86 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance. - . Prostate - Biopsy and minimally invasive puncture - . Surgical (Prostate) - Biopsy and minimally invasive puncture
    Device Description
    The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.
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    K Number
    K231666
    Device Name
    Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
    Manufacturer
    Fujifilm Healthcare Americas Corporation
    Date Cleared
    2023-12-13

    (189 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults. Modes of Operation: B-mode Never use this product for any other purposes.
    Device Description
    FUJIFILM Endoscopic Ultrasonic Probe converts the electrical signal from the ultrasonic observation device connected via the probe scanner into ultrasonic waves by the ultrasonic transducer placed and emits it and receives reflected waves from the human body. The received wave is converted into an electric signal by transducer and sent to an ultrasonic device to create an ultrasonic image. The scanning method is a mechanical radial method by using a probe scanner. Based on the guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 2023), this device follows the track 3 designation, as it does conform to IEC 60601-2- 37. The transducer model designation and type are a mechanical radial scan, with a size and spacing of elements of 1.9×2.0×0.6mm(M×L×T). There is one element in the array, with array dimensions of one and the maximum number of active elements for a single pulse is one. The nominal ultrasonic frequency of the P2612S-L is 10MHz and for P2620S-L is 17MHz, both in combination with SP-900.
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    K Number
    K231783
    Device Name
    VitroPRO
    Manufacturer
    CIVCO Medical Instruments Co., Inc.
    Date Cleared
    2023-11-14

    (151 days)

    Product Code
    ITX, MQE
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers. Transvaginal - Diagnostic ultrasound needle / instrument quided procedures such as tissue biopsy. fluid aspiration, catheter placement, treatment, and oocyte retrieval. Transrectal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.
    Device Description
    The VitroPRO disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.
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    K Number
    K223689
    Device Name
    Disposable Needle Guides and Grids
    Manufacturer
    Advance Medical Designs, Inc.
    Date Cleared
    2023-08-02

    (236 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    ITX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
    Device Description
    Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
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