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510(k) Data Aggregation

    K Number
    K201231
    Device Name
    CTxx85 CT Scanner
    Manufacturer
    Analogic Corporation
    Date Cleared
    2021-02-02

    (271 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Analogic Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of xray transmission data taken at different angles and planes. The CTXXX85 CT scanner systems are indicated for head and whole-body X-ray Computed Tomography applications for both pediatric and adult patients. The images delivered by the system can be used by a trained physician and trained healthcare professionals as an aid in diagnosis, treatment preparation and radiation therapy planning.
    Device Description
    The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration). The CTXX85 system is designed for routine radiological imaging procedures as well as advanced techniques such as coronary CT angiography, brain / organ perfusion, cardiac imaging with gated ECG, and CT-guided procedures. The CTXX85 system is designed with LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution and Iterative Bone Correction (IBC) in scan protocols associated with Head patient anatomy. The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box). Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder, QA phantom and mount, CIVCO table overlay and cardiac trigger module (CTM).
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    K Number
    K182147
    Device Name
    CTXX85
    Manufacturer
    Analogic Corporation
    Date Cleared
    2018-09-07

    (30 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Analogic Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Analogic CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 CT Scanner systems are indicated for pediatric and adult patients.
    Device Description
    The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration). The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution. The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box). Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.
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    K Number
    K172058
    Device Name
    CT6485, CT12885
    Manufacturer
    Analogic Corporation
    Date Cleared
    2018-02-13

    (222 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Analogic Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Analogic CTXX85 systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 systems are indicated for pediatric and adult patients.
    Device Description
    The CTXX85 is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are two models of the CTXX85 scanner: CT6485 (64 slice configuration) and CT12885 (128 slice configuration). The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution. The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box). Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.
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    K Number
    K161342
    Device Name
    Sonic Window
    Manufacturer
    ANALOGIC CORPORATION
    Date Cleared
    2016-06-15

    (33 days)

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

    ANALOGIC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. Intended Use: Diagnostic ultrasound imaging and visualization of vessels for vascular access guidance of needles and catheters as follows: Peripheral vascular
    Device Description
    The Sonic Window with the addition of software to perform and display ultrasound fluid flow analysis is a fully integrated handheld ultrasound imaging system that displays real-time ultrasound images on a coronal plane at a constant depth from the transducer. The depth is controllable by the operator. The Sonic Window system consists of the Sonic Window handheld device, the Docking Station/Charger and the AC Adapter. The Sonic Window uses an imaging mode, C-Mode, which provides the visualization in the coronal plane of peripheral vessels and assessment of vessels width and depth for needle/catheter placement.
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    K Number
    K140126
    Device Name
    SONIC WINDOW
    Manufacturer
    ANALOGIC CORPORATION
    Date Cleared
    2014-03-04

    (47 days)

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

    ANALOGIC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonic Window is intended for the visualization of vasular access guidance of needles and catheters (Insertion of Peripheral Intravenous (PIV) Catheters as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.
    Device Description
    The Sonic Window is a fully integrated handheld ultrasound imaging system that combines electronics, transducer, display and battery into the same device. The device is designed and optimized to visualize real-time ultrasound images on a Coronal (Constant Imaging Depth) plane positioned at a distance (depth) from the transducer that is controllable by the user.
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    K Number
    K070829
    Device Name
    SYNEPIX 4600 DETECTOR
    Manufacturer
    ANALOGIC CORPORATION
    Date Cleared
    2007-05-09

    (44 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANALOGIC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SynePix 4600 is Thallium-doped Cesium Iodide and amorphous Silicon (a-Si) Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. If is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. The detector will be used with Analogic AN6255 and AN6265 (SyneRad Omni and SyneRad Omni RT) Systems. The AN6255 has a single tall stand and single detector, the AN6265 is a dual detector system with a tall stand and short stand. The detector is not for use for mammography.
    Device Description
    The SynePix 4600 is a 17 inch by 17 inch digital detector. It is intended to convert Xrays into electrical signals to create usable images for diagnostic use.
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    K Number
    K051903
    Device Name
    FETALGARD LITE-NIBP, MODEL FGL-NIBP
    Manufacturer
    ANALOGIC CORPORATION
    Date Cleared
    2005-12-27

    (167 days)

    Product Code
    DXN, HGM
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANALOGIC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FETALGARD Lite-NIBP is a Perinatal Monitoring System for non-invasively measuring and showing graphically abdominal contractions, fetal heart rate, maternal non-invasive blood pressure, and maternal heart rate by means of display on a non-permanent graphical display and optionally on a printer. This data is to aid in assessing the well-being of the fetus and mother during the final trimester of pregnancy (non-stress test). This device is for use only by trained medical personnel located in hospitals, clinics, doctors' offices, and patient's home.
    Device Description
    The FETALGARD Lite-NIBP is a compact, lightweight device for measuring, processing, displaying, and printing information derived from four physiological measurements: - Fetal Heart Rate. Two types of ultrasound transducers can be used to monitor single or twins fetal heart rate and display real-time on the LCD screen or permanently recorded on the optional printer. - Uterine Activity. Uterine pressure changes via a tocotonometer are used to monitor uterine contractions. The waveforms are displayed real-time on the LCD screen or permanently recorded on the optional printer. - Maternal non-invasive blood pressure. Blood pressure is measured non-invasively (NIBP) by the oscillometric method. - Maternal heart rate. The algorithm used to derive maternal heart rate is identical to the derived heart rate parameter used in the C3 Patient Monitor when the NIBP module is the measurement source. A printer records fetal heart rate and tocotonometer waveforms, maternal non-invasive blood pressure value, and maternal heart rate value. The FETALGARD Lite-NIBP is powered by internal sealed lead-acid batteries or from the mains supply via an external battery eliminator. A fully charged battery will power the monitor for two hours minimum.
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