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510(k) Data Aggregation

    K Number
    K123681
    Device Name
    1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE, LTD.
    Date Cleared
    2013-02-22

    (84 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    WIPRO GE HEALTHCARE PRIVATE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MR1 systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
    Device Description
    The 1.5T 4CH Flex Coils are receive-only coils designed to provide images of various parts of human body. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging. The 1.5T 4CH Flex coils are available in two models – 1.5T 4CH Large Flex coil and 1.5T 4CH Small Flex Coil, and are designed for use with GE 1.5T MR systems. 1.5T 4CH Flex coils are General Purpose receive only coils with 4 elements and integrated preamplifiers. 1.5T 4CH Flex coils are based on phased array technique for combining the images from 4 different channels. Coils are tuned to the proton frequency of 63.86MHz.
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    K Number
    K121625
    Device Name
    LULLABY TM WARMER
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE, LTD.
    Date Cleared
    2012-09-14

    (105 days)

    Product Code
    FMT, REG
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WIPRO GE HEALTHCARE PRIVATE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infant radiant Warmers provide infrared heat in a controlled manner to infants who are unable to maintain thermoregulation based on their own physiology. Infant radiant Warmers may be used to facilitate the newborn's transition to the external environment or to rrovide a controlled open microenvironment.
    Device Description
    The Lullaby™ Warmer is a radiant warmer which provides a micro-environment for a premature, new born baby which otherwise might have very little chance of survival as it will not be able to maintain, by itself, its core body temperature. The Lullaby™ Warmer provides a means for the care giver to monitor the baby continuously by giving timely feedback via the different alarm systems and servo controlled thermal feedback mechanism while maintaining a pre-set temperature and thus ensures that the neonate slowly develops the internal organs to enable it to maintain its body temperature.
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    K Number
    K120168
    Device Name
    LULLABY LED PHOTTHERAPY SYSTEM
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE, LTD.
    Date Cleared
    2012-05-02

    (104 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    WIPRO GE HEALTHCARE PRIVATE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lullaby The LED Phototherapy System is used for the treatment of indirect hyperbilirubinemia in term and pre-term infants, in a hospital environment - NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner. The Lullaby 10 LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner. The Lullaby The LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.
    Device Description
    The Lullaby™ LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. The system can be used for infants in a bassinet, incubator, open bed or radiant warmer. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum range. The Lullaby™ LED Phototherapy System consists of a lamp unit with 10 blue LED lamps mounted on a roll stand. The lamp unit consists of a lightweight plastic light enclosure. It can be adjusted vertically and tilted if required. The light enclosure can be tilted up to approximately 90° from the horizontal about it pivot axis. The height of the pedestal can be adjusted to change the vertical position of the lamp unit. The base of the Lullaby™ LED Phototherapy System is designed to slide conveniently under a bassinet, incubator, open bed, or radiant warmer. The lamp unit is designed as a table top style to place directly on the incubator
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    K Number
    K110556
    Device Name
    MINI TELEMETRY SYSTEM
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE, LTD.
    Date Cleared
    2011-07-19

    (141 days)

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

    WIPRO GE HEALTHCARE PRIVATE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal fetal monitor during the ante partum period and during labor. The system allows ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination. The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner in a defined coverage area. The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.
    Device Description
    The Mini Telemetry System provides a wireless means of transmitting heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal/fetal monitor. It includes receiver (RX 2051412-004) and transmitter (TX 2051411-004) subsystems. The system monitors fetal heart rate through ultrasound Doppler technology, ECG (Fetal ECG or Maternal ECG), and uterine activity (TOCO or IUPC) signals individually or in combination. The transmitter stays along with mother acquiring data from transducers and transmitting it to the remote Receiver placed next to the monitor in the room. The Mini Transmitter is carried by the mother using the strap mechanism. One end of the transducers are connected to the transmitter and the other end comes in contact with the mother to acquire data. This system acquires and transmits data wirelessly to the receiver. The Mini Telemetry system itself is an accessory to the main fetal/maternal fetal monitor. The Mini Telemetry system is compatible with the following Corometrics brand monitors: CORO 170 Series fetal monitors K993751 / K991905 CORO 120 Series Maternal fetal monitors K0332252 CORO 250 Series Maternal fetal monitors K050583
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    K Number
    K102104
    Device Name
    GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE, LTD.
    Date Cleared
    2010-10-01

    (66 days)

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

    WIPRO GE HEALTHCARE PRIVATE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Cardiac (adult and pediatric), Peripheral Vascular. Fetal/Obstetrics. Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculo-skeletal Conventional, Urology (including prostate). Transrectal and Transvaginal.
    Device Description
    The VividTM P3 is a high performance, mobile Color Doppler Ultrasound Imaging system. This system is designed for cardiovascular applications and including abdominal neonatal/pediatrics & intra-operative. It is integrated with keyboard control panel, LCD type video display and interchangeable electronic-array transducers.
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