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The SAMI RRT Unit is a software controlled device that performs the following functions:
- Primes the disposable cassette automatically.
- Pumps blood through the blood flow path of the disposable cassette.
- Delivers anticoagulant into the blood flow path.
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy
in use.
- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies.
- Controls the patient fluid removal or plasma loss according to the therapy in use.
- Monitors the system and alerts the operator to abnormal situations through alarms.
The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the Cassette tubing set.
Spectral Medical Inc
SM-100-003
Not in Commercial Distribution
- B173SM1000030 ()
SM-100-003
- Haemodialysis system, institutional
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility.
The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure.
Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
Compremium AG
1
In Commercial Distribution
- G247CPMX10 ()
- G247CPMX12 ()
- Compartmental-pressure monitoring system, reusable
MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their
diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with
accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway
using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the
MoMe® Software Platform (K152491) over a 4G LTE cellular link.
The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway
battery being wirelessly charged by the charging dock and the sensor battery being wirelessly
charged by Gateway.
Infobionic, Inc.
30000
In Commercial Distribution
- B690MA10 ()
- Patient monitoring system module, electrocardiographic, telemetric
The SAMI RRT Unit is a software controlled device that performs the following functions:
- Primes the disposable cassette automatically,
- Pumps blood through the blood flow path of the disposable cassette,
- Delivers anticoagulant into the blood flow path,
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,
- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,
- Controls the patient fluid removal or plasma loss according to the therapy in use,
- Monitors the system and alerts the operator of abnormal situations through alarms.
The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Dialco Medical Inc
SA-100-01
In Commercial Distribution
- B815SA100010 ()
SA-100-01
- Haemodialysis system, institutional
The SAMI RRT Unit is a software controlled device that performs the following functions:
- Primes the disposable cassette automatically,
- Pumps blood through the blood flow path of the disposable cassette,
- Delivers anticoagulant into the blood flow path,
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,
- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,
- Controls the patient fluid removal or plasma loss according to the therapy in use,
- Monitors the system and alerts the operator of abnormal situations through alarms.
The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Dialco Medical Inc
SM-100-003
In Commercial Distribution
- B815SM1000030 ()
SM-100-003
- Haemodialysis system, institutional
The DIMI RRT System is a software controlled device that performs the following functions:
- Primes the disposable cassette automatically,
- Pumps blood through the blood flow path of the disposable cassette,
- Delivers anticoagulant into the blood flow path,
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,
- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,
- Controls the patient fluid removal or plasma loss according to the therapy in use,
- Monitors the system and alerts the operator of abnormal situations through alarms.
The DIMI RRT System has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Dialco Medical Inc
DM-850-00
In Commercial Distribution
- B815DM850000 ()
DM-850-00
- Haemodialysis system, institutional/home-use
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin.
Instrumentation Difra SA
NysStar II
In Commercial Distribution
- B516221340 ()
22134
- Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR I is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). NYSSTAR I is able to record all eye movements, as well horizontal, as vertical and even rotary movements on option. The calibration carried out by NYSSTAR I is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin.
Instrumentation Difra SA
NysStar I
In Commercial Distribution
- B516221280 ()
22128
- Electronystagmograph
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Convergent Imaging Solutions Incorporated
7-4-1-PX
In Commercial Distribution
- B843UNISYN7410 ()
- Radiology picture archiving and communication system workstation
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.
medimaps group SA
3.1.2
- Bone absorptiometric x-ray system, dual-energy