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A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages.
LINKQUEST INC.
Model SQ860
In Commercial Distribution
- 00860000784801 ()
- General-purpose ultrasound imaging system
A sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.
INDILAB INC.
IND400S
Not in Commercial Distribution
- 00860000763615 ()
- 00860000763608 ()
- Length: 4 Inch
IND400S
- Chemical/physical sterilization process indicator
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution
- 00860000709408 ()
- Depth: 73 Millimeter
- Width: 113 Millimeter
- Height: 40 Millimeter
- Cognitive assessment software
Turbine Assembly, Bagged for GoSpiro Spirometer
MONITORED THERAPEUTICS, INC.
45-90133
In Commercial Distribution
- 00860000692823 ()
45-90133
- Diagnostic spirometer, professional
Device Description:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics
and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a
Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops
including inspiratory and expiratory data. The internal program performs all of the calculations for
measurements to meet American Thoracic Society and European Respiratory Society requirements. It has
built-in quality control measurements and transmits indices of measurement quality including time to peak
flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.
It is used with the GoSpiro App display and communications software on a smartphone or tablet.
The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging
station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC
60601-1-11.
The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer
measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus
avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the
device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This
transducer is insensitive to the effects of condensation and temperature and avoids the need for individual
calibration prior to performing a test.
Indications for Use:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics
and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.
MONITORED THERAPEUTICS, INC.
45-90058
In Commercial Distribution
- 00860000692809 ()
45-90058
- Diagnostic spirometer, professional
NTrainer System
INNARA HEALTH, INC.
A10002
In Commercial Distribution
- 00860000688611 ()
A10002
- Evoked-potential graphic recording system
NTrainer System
INNARA HEALTH, INC.
A00002
In Commercial Distribution
- 00860000688604 ()
A00002
- Evoked-potential graphic recording system
Aluna Spirometer
KNOX MEDICAL DIAGNOSTICS INC.
000050-FGI
In Commercial Distribution
- 00860000654005 ()
- Expiratory peak flow meter, digital
No Description
Hyperfine Operations, Inc.
Version 1.0
In Commercial Distribution
- 00860000606189 ()
- Image segmentation application software
Swoop POC MRI Scanner (Mk1.8 version)
Hyperfine Operations, Inc.
850-11001-05
In Commercial Distribution
- 00860000606172 ()
- Extremity MRI system, permanent magnet