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The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network.
The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.
VIVAQUANT, INC.
RX-1 mini
In Commercial Distribution
- 00860000272407 ()
- Electrocardiographic long-term ambulatory recording analyser application software
The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by
medical professionals whenever it is required to assess a patient’s long-term, continuous,
ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memory
Holter recorder. This product allows a trained physician, or other health care professional, to
download and analyze the data from the recorder, review it, and produce printed reports. This will
enable:
The evaluation of arrhythmias and ischemic attacks.
The reporting of PQRST intervals.
Clinical and epidemiological research studies.
The evaluation of a patient’s response after resuming occupational or recreational activities (e.g.,
after M.I. or cardiac surgery).
The evaluation of patients with Pacemakers.
The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered in
the Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient.
This device is available for sale to, or on the order of, a licensed physician only and is not intended
for any home-use applications.
SCOTTCARE CORPORATION, THE
HolterCare
In Commercial Distribution
- 00856298006169 ()
100087
- Electrocardiographic long-term ambulatory recording analyser application software
MARS V8
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V8
Not in Commercial Distribution
- 00840682100069 ()
- Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution
- B972CCZ12050482080 ()
CCZ1205048208
- Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution
- B972CCZ12050482050 ()
CCZ1205048205
- Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution
- B972CCZ12050482030 ()
- Electrocardiographic long-term ambulatory recording analyser application software
Nuubo Leonardo Box USA. Software for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device.
SMART SOLUTIONS TECHNOLOGIES SL
1935
In Commercial Distribution
- 08437011759092 ()
1935
- Electrocardiographic long-term ambulatory recording analyser application software
The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction.
INOVA DIAGNOSTICS, INC.
ALDR1000
In Commercial Distribution
- 08426950643708 ()
- Cell morphology analyser IVD, automated/semi-automated
NOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. Optional AutoLoader available as an accessory.
INOVA DIAGNOSTICS, INC.
NV2000
In Commercial Distribution
- 08426950621614 ()
- Cell morphology analyser IVD, automated/semi-automated
Holter Server Analyzer
Lifesignals, Inc.
UA2251-SA
In Commercial Distribution
- B353UA2251SA1 ()
- Electrocardiographic long-term ambulatory recording analyser application software