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510(k) Data Aggregation
K Number
K133622Device Name
MAC 2000 ECG ANALYSIS SYSTEM
Manufacturer
Date Cleared
2014-01-23
(62 days)
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
WIPRO GE HEALTHCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MAC™ 2000 ECG analysis system is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional's facility, clinics, physician`s office or outreach centers.
NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years.
The MACTM 2000 ECG analysis system provides the following modes of operation:
- Resting ECG mode .
- . Arrhythmia mode
- Exercise mode for exercise stress testing (optional) .
- RR analysis mode for RR interval analysis (optional) .
The basic system prints 6 or 12 leads of ECG and is upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Arrhythmia detection is provided for the convenience of automatic documentation.
Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
Device Description
The MACTM 2000 ECG analysis system can print and display multiple leads of ECG data. The device is capable of acquiring 2 additional ECG leads beyond what is needed for classical 12 lead ECG acquisition.
The MACTM 2000 ECG analysis system provides ECG measurement in both resting and stress mode. The device also supports arrhythmia as a mode of operation.
The Hook up advisor feature in MAC™ 2000 ECG analysis system advises the users of poor lead quality based on noise measurement.
The MACT14 2000 ECG Analysis System delivers multiple leads of ECG on full-size reports and includes an alphanumeric keyboard for patient demographics and other data entry, an integrated 7' color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non real time reports.
The device has an optional feature of transmission and reception of ECG data, downloading of orders and patient demographics to and from a central ECG cardiovascular information system and supports exporting of ECG records in PDF. It also has an optional internal memory and removable storage to store resting ECG records.
The patient information can be entered with the help of optional bar code reader.
Clinical Trials Data Guard and audit trail options are also available to support electronic record requirements.
MAC™ 2000 ECG Analysis system can be used as a portable unit also.
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K Number
K123681Device Name
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
Manufacturer
Date Cleared
2013-02-22
(84 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
WIPRO GE HEALTHCARE PRIVATE, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K121625Device Name
LULLABY TM WARMER
Manufacturer
Date Cleared
2012-09-14
(105 days)
Regulation Number
880.5130Why did this record match?
Applicant Name (Manufacturer) :
WIPRO GE HEALTHCARE PRIVATE, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K120168Device Name
LULLABY LED PHOTTHERAPY SYSTEM
Manufacturer
Date Cleared
2012-05-02
(104 days)
Product Code
Regulation Number
880.5700Why did this record match?
Applicant Name (Manufacturer) :
WIPRO GE HEALTHCARE PRIVATE, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K110556Device Name
MINI TELEMETRY SYSTEM
Manufacturer
Date Cleared
2011-07-19
(141 days)
Product Code
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
WIPRO GE HEALTHCARE PRIVATE, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K102104Device Name
GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Manufacturer
Date Cleared
2010-10-01
(66 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
WIPRO GE HEALTHCARE PRIVATE, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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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