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510(k) Data Aggregation

    K Number
    K021966
    Device Name
    Q LAB SOFTWARE
    Manufacturer
    ADVANCED TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    2002-07-02

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Device Description
    The O LAB software provides a means of opening and displaying image files. The O LAB software provides a means of creating AVI and BMP files from the image data displayed by the software. The Q LAB software provides a means of quantifying the image data using a plugin module designed to operate with the core engine of the software. The O LAB software provides a means for performing an automatic distance measurement of the intima media thickness of an artery represented in the image file data. The Q LAB software provides a means of creating region of interest figures overlaid on the image data displayed by the software. The Q LAB software provides a means of analyzing the content of the image data contained within the ROI figure. The Q LAB software provides a means of presenting the ROI data in an XY graphic format. The O LAB software provides a means to perform a curve fit operation on a data set generated by the ROI analysis software. The O LAB software provides a means of exporting the data generated by the plugin modules in a form accessible to the end user.
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    K Number
    K011224
    Device Name
    HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
    Manufacturer
    ADVANCED TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    2001-05-04

    (14 days)

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

    ADVANCED TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002144
    Device Name
    MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
    Manufacturer
    ADVANCED TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    2000-09-28

    (73 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992470
    Device Name
    ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
    Manufacturer
    ADVANCED TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1999-08-23

    (28 days)

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

    ADVANCED TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Intra-operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans. Intraoperative application including soft tissue structures.
    Device Description
    The UM 400C/SA 6000C system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D, Tissue Harmonic Imaging or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The UM 400C/SA 6000C also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Nine different models of transducers are available and any two may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The UM 400C/SA 6000C system uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is a diagnostic ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 9.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The UM 400C/SA 6000C supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a Dicom 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
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    K Number
    K991671
    Device Name
    HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    ADVANCED TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1999-06-18

    (32 days)

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

    ADVANCED TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HDI 5000 system is intended for ophthalmic, fetal, abdominal, intraoperative, pediatric, small organ, adult and neonatal cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal (conventional and superficial) intended uses as defined in the FDA guidance document. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal, vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
    Device Description
    The HDI 5000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, M-mode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA), 3D, or in a combination of modes. The HDI 5000 system also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HDI 5000 has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Advanced Image Processing is a feature upgrade to the HDI 5000 Ultrasound System that adds enhanced DSP image processing hardware and proprietary software algorithms to improve 2D image quality. The sub-systems affected by the software algorithms include the beamformer, signal processing, and image processing modules. The enhanced DSP hardware approximately doubles the image processing power of the HDI 5000 system, allowing processed images to be generated in real time with no loss of frame rate. The benefits of Advanced Image Processing include enhanced contrast resolution, improved tissue texture definition, clutter reduction, and better definition and continuity of tissue interfaces.
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    K Number
    K961459
    Device Name
    LEVEL 10 HDI
    Manufacturer
    ADVANCED TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1997-03-26

    (344 days)

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

    ADVANCED TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents. Typical examinations using Level 10 HDI are: - General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies. - Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall. - Pediatric scans of organs, superficial, and bony structures. - Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. - Monitoring procedures for infertility studies (other than in vitro fertilization). - First, second and third trimester pregnancy studies. - Prostate, prostate biopsy guidance, and rectal wall studies. - Neonatal head studies. - Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. - Cardiac studies in adults and children. - Monitoring of cardiac function during procedures using transesophageal echocardiography. - Biopsy guidance for tissue or fluid sampling. - Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery - Study of myocardial function in adults - Study of eye anatomy including blood flow in retinal vessels and branches - Study of the esophagus, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe - Study of abdominal and pelvic organs and masses using laparoscopic probe - Examination of organs, masses and vessels during surgical procedures - Study of muscles, ligaments, nerve bundles and connective tissue
    Device Description
    Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, Mmode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes. Level 10 HDI also gives the opertor the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. Level 10 HDI has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The Level 10 HDI system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel. The Level 10 HDI system is designed to accept scanheads of the following types and frequency: frequency range: 2.0 - 10.0 MHz scanhead types: Linear array Curved linear array Phased array Static probes Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.
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