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
• High Resolution Knee Arrays |
• Home Use Apnea Monitor (FDA Code: NPF / 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. |
• Home Use Continuous Ventilator (FDA Code: NOU / 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. |
• Hydraulic Photo-Electric Plethysmograph (FDA Code: JOM / 870.2780) A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. |
• Image-Intensified Fluoroscopic X-Ray System (FDA Code: JAA / 892.1650) An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Impedance Plethysmograph (FDA Code: DSB / 870.2770) An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. |
• Implantable Radiographic Marker (FDA Code: NEU / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. |
• Infant Disposable Blood Pressure Cuffs |
• Infant Heel Warmer (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. |
• Instrument Surgical Guide (FDA Code: FZX / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Light Beam Patient Position Monitor (FDA Code: IWE / 892.5780) A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy. |
• Liquid Crystal Forehead Temperature Strip (FDA Code: KPD / 880.2200) A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic. |
• Liquid Medication Dispenser (FDA Code: KYX / 880.6430) A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication. |
• Low Energy DC-Defibrillator (FDA Code: LDD / 870.5300) A low-energy DC-defibrillator is a device 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 or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. |
• Luminescence Breast Systems |
• Manual Radiographic Collimator (FDA Code: IZX / 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. |
• Manual Stethoscope (FDA Code: LDE / 870.1875) A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. |
• Medical Cathode-Ray Tube Display (FDA Code: DXJ / 870.2450) A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal. |
• Medical Linear Accelerator (FDA Code: IYE / 892.5050) A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories. |
• Medical Magnetic Tape Recorder (FDA Code: DSH / 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. |
• Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger. |
• Mobile Fluoroscopic X-Ray System (FDA Code: IZL / 892.1720) A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Mobile X-Ray System (FDA Code: IZL / 892.1720) |
• Monitoring Spirometer (FDA Code: BZK / 868.1850) A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. |
• Monopolar Electrode Cables |
• MRI Safe Blood Pressure Cuff |
• MRI Systems |
• Multi-Function Electrocardiograph Electrode (FDA Code: MLN / 870.2360) An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. |
• Needle Blocks |
• Needle Sleeves |
• Neonatal Apnea Monitor (FDA Code: FLS / 868.2377) |
• Neonatal Disposable Blood Pressure Cuffs |
• Neonatal Eye Pad (FDA Code: FOK / 880.5270) A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy. |
• Neonatal Phototherapy Unit (FDA Code: LBI / 880.5700) A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts. |
• Neonatal Total Bilirubin Test System (FDA Code: MQM / 862.1113) A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus). |
• Non Invasive External Transcutaneous Cardiac Pacemaker (FDA Code: DRO / 870.5550) An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles. |
• Non-Continuous Ventilator/Respirator (FDA Code: BZD / 868.5905) A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing. |
• Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN / 870.1130) A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body. |
• Non-Invasive Tubing (FDA Code: GAZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• Non-Life Supporting Continuous Ventilator (FDA Code: MNS / 868.5895) |
• Nuclear Magnetic Resonance Imaging System (FDA Code: LNH / 892.1000) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). |
• Obstetric Ultrasonic Transducer (FDA Code: HGL / 884.2960) An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, the body in conjunction with an obstetric monitor or imager. The device converts electrical signals into ultrasonic energy, and vice versa, by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessories: coupling gel, preamplifiers, amplifiers, signal conditioners with their power supply, connecting cables, and component parts. This generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application. |
• Open Breast Arrays |
• Operating-Room Table and Attachments (FDA Code: BWN / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures. |
• Orthopedic Drilling Systems |
• Over-The-Counter Automated External Defibrillator (FDA Code: NSA / 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. |
• Oximeters (FDA Code: DQA / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. |
• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. |
• Paper Chart Recorder (FDA Code: DSF / 870.2810) A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer. |
• Patient Physiological Monitor (FDA Code: MHX / 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. |