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The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of
delivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT),
stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT
(kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice width
choices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileaf
collimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. It
can achieve a nominal dose rate of 850 cGy/min.
REFLEXION MEDICAL, INC.
RXM1000
In Commercial Distribution
- 00860003983805 ()
- Linear accelerator system
PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometry. Bluetooth connectivity allows remote monitoring and visualization on mobile devices.
Cognita Labs, LLC
PulmoScan-FOT
In Commercial Distribution
- 00860003953716 ()
- Pulmonary function analysis system, adult
- Pulmonary function analysis system, paediatric
CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.
Cognita Labs, LLC
CAPMED-C
In Commercial Distribution
- 00860003953709 ()
- Inhaler dose sensor
- Diagnostic spirometer, professional
The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.
The device can record a single channel of ECG data in three ways: (I) via the two thumb electrodes, (2) by applying wrist electrodes or (3) applying two sticky electrodes as instructed by their health care practitioner. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm.
The built-in graphical LCD display indicates the presence or absence of AF. If ECG data is present (whether or not AF is indicated) the device uses an internal cellular module to transfer the ECG data to the cloud to be viewed and/or shared with their physician or health care practitioner using either company developed or third party developed internet based software program(s).
LOHMAN TECHNOLOGIES, LLC
V2.0
In Commercial Distribution
- 00860003939734 ()
790.102.200
- Electrocardiograph, home-use
The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred 45-second events in solid-state non-volatile memory. AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.
The device can record a single channel of ECG data in four ways: (I) via the two thumb electrodes, (2) by placement on the chest, (3) by applying wrist electrodes or (4) applying two sticky electrodes as instructed by their physician. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF.
If AF is indicated, or concerning symptoms are present, the patient can either use a Bluetooth connection to a smart device or use a USB connection to a computer to transfer their ECG data to be viewed and/or shared with their physician.
LOHMAN TECHNOLOGIES, LLC
V1.5
Not in Commercial Distribution
- 00860003939703 ()
- 00860003939710 ()
- 00860003939727 ()
790.0102.001
- Electrocardiograph, home-use
CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835)
PRAXIS MEDICAL LLC
C0025L
In Commercial Distribution
- 00860003935866 ()
- 00860003935835 ()
- Biopsy syringe holder, single-use
The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor which rotates the needle clockwise and counterclockwise motion to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.
PRAXIS MEDICAL LLC
C0025
In Commercial Distribution
- 00860003935804 ()
- 00860003935811 ()
- 00860003935828 ()
- Biopsy syringe holder, reusable
SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SpineAR
In Commercial Distribution
- 00860003884126 ()
- Surgical planning/navigation-enhancement system
SuRgical Planner (SRP) BrainStorm Desktop System
SURGICAL THEATER LLC
BrainStorm
In Commercial Distribution
- 00860003884119 ()
- Surgical simulation system
SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SyncAR
In Commercial Distribution
- 00860003884102 ()
- Surgical planning/navigation-enhancement system