Profile: Invivo specializes in MRI monitoring, which provides accurate vital signs for improved patient safety. Our 4500 MRI pulse oximeter uses advanced fiberoptic technology to provide accurate SpO2 readings and heart rate measurements during magnetic resonance imaging. This product clearly represents the best value in MRI saturation monitoring available today. It is specifically designed for use in the magnetic resonance imaging environment. It eliminates RF interference and oximeter RF leakage problems. Versatile AC power or battery operation allows the Invivo 4500 MRI Pulse Oximeter to be used in both magnetic resonance imaging suites and mobile imaging facilities. The compact size, light weight, and optional aluminum cart permit ease of operation, viewing, and portability in the magnet room.

The company was founded in 1987, has revenues of USD 10-25 Million and is ISO 9001, CE certified. NASDAQ:SAFE (SEC Filings)

FDA Registration Number: 1056069

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• Airway Pressure Monitor (FDA Code: CAP / 868.2600) An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

• Airway Pressure Monitor with Alarm (FDA Code: CAP / 868.2600)

• Airway Pressure Monitor with Gauge (FDA Code: CAP / 868.2600)

• Ambulatory Electrocardiograph (FDA Code: MWJ / 870.2800) A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

• Ambulatory Electrocardiograph (ECG) Analysis Systems (FDA Code: MLO / 870.2800)

• Anesthesia Gas-Machine (FDA Code: BSZ / 868.5160) A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.

• Anesthesia Inhalation Breathing Gases Mixer (FDA Code: BZR / 868.5330) A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

• Anesthetic Gas Mask (FDA Code: BSJ / 868.5550) An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.

• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650) An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

• Angiographic X-Ray System (FDA Code: IZI / 892.1600) An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Antimicrobial Blood Pressure Cuff (FDA Code: OED / 870.1120) A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

• Apnea Monitors (FDA Code: FLS / 868.2377) An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

• Arrhythmia Detector and Alarm (FDA Code: DSI / 870.1025) The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

• Aspiration Needles

• Automatic External Defibrillator (FDA Code: MKJ / 870.5310) An automated external defibrillator (AED) is a low-energy device with a rhythm recognition detection system that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart. An AED analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

• Automatic Radiographic Collimator (FDA Code: IZW / 892.1610) A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

• Automatic Radiographic Film Processor (FDA Code: IXW / 892.1900) An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

• Battery-Powered Transilluminator (FDA Code: HJN / 886.1945) A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.

• Bed Patient Monitor (FDA Code: KMI / 880.2400) A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

• Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Bipolar Electrode Cables

• Blood Irradiator (FDA Code: MOT)

• Blood Pressure Computer (FDA Code: DSK / 870.1110) A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.

• Blood Pressure Cuff Barriers

• Blood Pressure Cuff With Inflation Systems

• Blood pressure Cuffs (FDA Code: DXQ / 870.1120)

• Blood Pressure Cuffs and Neoprene Bladders (1-Tube)

• Blood Pressure Cuffs and Neoprene Bladders (2-Tube)

• Blood Pressure Cuffs With Bayonet Connectors

• Blood Pressure Cuffs With Locking-Type Connectors

• Blood Pressure Cuffs With Luer Lock Connectors

• Blood Pressure Cuffs With Screw-Type Connectors

• Bone Biopsy Sets

• Breast Biopsy Arrays

• Breathing Frequency Monitor (FDA Code: BZQ / 868.2375) A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 868.2377.

• Cardiac Monitor (Cardiotachometer and Rate Alarm) (FDA Code: DRT / 870.2300) A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

• Cardiopulmonary Bypass On-Line Blood Gas Monitor (FDA Code: DRY / 870.4330) A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.

• Cardiopulmonary Resuscitation Aid (FDA Code: LIX / 870.5210) An external cardiac compressor is an external device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest.

• Cardiovascular Arrays

• Carotid Sinus Nerve Stimulator (FDA Code: DSR / 870.3850) A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus.

• Channel Breast Arrays

• Chemical Heat Pack (FDA Code: MPO / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• Chest X-Ray Computer Aided Detection (FDA Code: OMJ / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Coaxial Needles

• Computed Tomography X-Ray System (FDA Code: JAK / 892.1750) A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Conmed Electrosurgery

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910) A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

• Continuous Ventilator (FDA Code: CBK / 868.5895) A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.