Search Filters

Search Results

Found 15 results

510(k) Data Aggregation

    K Number
    K172931
    Device Name
    DUS-6000 Digital Ultrasonic Diagnostic Imaging System
    Date Cleared
    2017-12-01

    (67 days)

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

    Advanced Instrumentations, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.
    Device Description
    The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a portable diagnostic ultrasound system, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging (eSRI), scan receiving aperture (SRA) and Spatial Compounding Imaging. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically. The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.
    Ask a Question

    Ask a specific question about this device

    K Number
    K141194
    Device Name
    FM-3000 FETAL MONITOR
    Date Cleared
    2014-11-19

    (195 days)

    Product Code
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FM-3000 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. It provides Non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity via a pressure sensing transducer. Alternatively, it can internally monitor one of the fetal heart rates with an electrocardiograph and uterine activity with an intrauterine pressure catheter.
    Device Description
    With non-invasive ultrasound Doppler, external pressure sensing transducer and direct fetal electrocardiograph technique, the FM-3000 Fetal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity. Alternatively, it can internally monitor one of the fetal heart rate with direct fetal electrocardiograph technique and uterine activity with an Intrauterine Pressure Catheter. The Fetal monitor can be connected with Central Monitoring System via a RJ45 interface. Also it can be connected to wireless network module via a DB9 interface, and the wireless network module will complete the data switch of the monitor and the Obstetrical Central Monitoring System. The FM-300 is not intended for use in intensive care units, operating rooms or for home use.
    Ask a Question

    Ask a specific question about this device

    K Number
    K132077
    Device Name
    PATIENT MONITOR
    Date Cleared
    2014-04-23

    (292 days)

    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (Sp02), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired C02, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.
    Device Description
    The PM-2000M Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormities happen. The PM-2000M realizes the monitoring of physiological parameters by configuration with different parameter modules which include Sp02 (pulse oxygen saturation, pulse rate and Sp02 plethysmogram) with EDAN Sp02 module or Nellcor SP02 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, C02, IBP, C.O. and AG. The above is the maximum configuration for elite VB, the user may select different monitoring parameters in according with the requirement. The PM-2000M is configured with a 17-inch touch screen and build-in Lithium-ion battery, Besides, and supports software upgrade online and networking
    Ask a Question

    Ask a specific question about this device

    K Number
    K132059
    Device Name
    DIAGNOSTIC ULTRASOUND SYSTEM
    Date Cleared
    2013-10-25

    (114 days)

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

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
    Device Description
    The DUS-5000 Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz.
    Ask a Question

    Ask a specific question about this device

    K Number
    K123048
    Device Name
    PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
    Date Cleared
    2013-01-11

    (105 days)

    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The monitor monitors parameters such as ECG (3-lead or 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02. The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
    Device Description
    The Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. The Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, C02, IBP. The above is the maximum configuration; the user may select different monitoring parameters in according with specific requirements. The main difference between Patient Monitor models is the screen size as it is illustrated in the table below: | Product models | Size (LxWxH) | Screen size | Monitoring features | |----------------|-------------------|-------------|----------------------------------------| | PM-2000A | | 10.1-Inch | | | PM-2000A+ | 320mmx150mmx265mm | 10.4-Inch | ECG/RESP.SPO2, NIBP,<br>TEMP, IBP, CO2 | | PM-2000A Pro | | 12.1-Inch | |
    Ask a Question

    Ask a specific question about this device

    K Number
    K120075
    Device Name
    AM-6000 ANESTHESIA MACHINE
    Date Cleared
    2012-01-26

    (16 days)

    Product Code
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AM-6000 Anesthesia machine is intended for general anesthesia use. The AM-6000 Anesthesia machine will delivery operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. AM-6000 Anesthesia machine is also intended to allow for the provision of manual ventilation.
    Device Description
    The AM-6000 Anesthesia Machine is a continuous flow Anesthesia Machine which offers manual or automatic vehtilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The AM-6000 is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the AM-6000 provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the AM-6000 with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional Anesthesia Machine along with dual flow tubes which display the gas flows at all times. The AM-6000 contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.
    Ask a Question

    Ask a specific question about this device

    K Number
    K112317
    Device Name
    FM-9000 PLUS FETAL AND MATERNAL MONITOR
    Date Cleared
    2011-12-21

    (132 days)

    Product Code
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FM-9000 Plus Fetal and Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartumn examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartumn examination rooms, labor and delivery rooms. The FM-9000 Plus Fetal and Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.
    Device Description
    The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations: - Basic parameters: FHR, TOCO, Event Mark, AFM . - Dual FHR monitoring . - Internal parameters: UIP, DECG . - FHR limit alarm . Following facilities are also provided in addition to the above: - Maternal ECG monitoring ● - Maternal SP02 monitoring ● - Maternal NIBP . - Maternal temperature monitoring ●
    Ask a Question

    Ask a specific question about this device

    K Number
    K112529
    Device Name
    TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
    Date Cleared
    2011-10-27

    (57 days)

    Product Code
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultrasonic Tabletop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.
    Device Description
    Ultrasonic Tabletop Doppler provides the following primary features: - Basic parameters: FHR - 240 seconds fetal heart sound record and playback - Infrared communication (for TD-6000 only) - Ni-MU1 battery for 20 hours continuous working of main unit - Li-ion battery for 2.5 hours continuous working of TD-6000 probe - Charge the TD-6000 probe battery by main unit - Continuous wave Doppler transducer for FUR detection
    Ask a Question

    Ask a specific question about this device

    K Number
    K111934
    Device Name
    PD-100 SERIES ULTRASONIC POCKET DOPPLER
    Date Cleared
    2011-09-22

    (76 days)

    Product Code
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PD-100 series Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians' assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K112022
    Device Name
    DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
    Date Cleared
    2011-09-22

    (69 days)

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

    ADVANCED INSTRUMENTATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS-3000/DUS-3000Plus is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrectal and Transvaginal.
    Device Description
    The DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic BMV system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into the body tissue and to present the returned echo information on the monitor. The resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode or the combined mode (i.e. B/M-Mode). This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, micro convex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10MHz. The system consists of a main unit, a display and transducers.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 2