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ArtUs is a general purpose diagnostic ultrasound imaging system intended for use by qualified and appropriately trained healthcare professionals to conduct ultrasound scan process or fluid flow analysis of the human body. It is intended to be used for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicles), Musculo-Skeletal Conventional and Superficial, Cardiac (adult and pediatric), Adult Cephalic, and Peripheral Vascular. Modes of operation include B, M, Pulse Wave Doppler (CFM), Power Doppler (CFM), Power Doppler (PDI), Directional Power Doppler (DPDI), Combined modes (B+B, B+M, 4B, B+PWD (Duplex), B+CFM/PDI/DPDI+PWD (Triplex)), Tissue Harmonic Imaging (THI) and Inverted Tissue Harmonic Imaging (ITHI). The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.

ArtUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. ArtUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, M-Mode or combined modes, inclusive of the predicate devices so claimed. The ArtUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the ArtUs via USB 3.0. Minimum requirements are given for the PC. The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC. The device variant is: - ArtUs EXT-1H ultrasound system utilizing as hardware an ultrasound engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply; The ArtUs can be used together with the appropriate transducers for the entire ultrasound diagnostic (2MHz to 15MHz probes).

SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel (B and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at thebedside systems, for navigatedmedical application, in operating rooms/critical care units.

SmartUs EXT-1M/3M system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. SmartUs EXT-1M/3M system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode, M-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, M-Mode or combined modes, inclusive of the predicate devices so claimed. SmartUs EXT-1M/3M only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the SmartUs EXT-1M/3M via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC. The device modifications are: - SmartUs EXT-1M ultrasound system utilizing as hardware an ultrasound ● engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply; - SmartUs EXT-3M ultrasound system -modification with 3 probe ports ● The SmartUs EXT-1M/3M can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes). - . probe L15-7L40H-5, linear array, at a central ultrasonic frequency of approx. 12 MHz; - probe C5-2R60HI-5, convex array at a central ultrasonic frequency of approx. 3.5 MHz; ● - probe P5-1L15SI-6, phased array at a central ultrasonic frequency of approx. 4 MHz. ●

MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigation, in operating rooms/critical care units.

MicrUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. MicrUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 15 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, inclusive of the predicate devices so claimed. The MicrUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the MicrUs via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC. The basic modification MicrUs EXT-1H ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port. The MicrUs can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).

The TM eCloud ECG Analysis System, using proprietary algorithm, is intended for use in adults and children of any age from birth upwards. The Program makes significant use of the patient's age and gender and will provide a unique diagnosis if age differs only by a few days in the case of neonates. It is a program that is based on normal limits derived using the algorithm itself with this applying to criteria for subjects of all ages, including neonates. TM eCloud ECG Analysis System is qualified to evaluate, detect, and aid in the physician diagnosis of the following cardiac arrhythmias and/or conduction defects: - o Evaluation of symptoms that may be caused by cardiac arrhythmia and /or conduction disturbances - Evaluation of symptoms that may be due to myocardial ischemia - Detection of ECG events that alter prognosis in certain forms of heart disease - Detection and analysis of indirect pacemaker function and failure - Determination of cardiac response to lifestyle - Evaluation of therapeutic interventions - . Investigations in epidemiology and clinical trials - Evaluation of heart rate variability in the assessment of heart disease TM eCloud ECG Analysis System is intended to provide an interpretation of up to 12-channel ECG in all situations including resting and ambulatory ECG including Holter, cardiac event, and mobile cardiac telemetry. This software qualifies to be used in hospitals, physician offices, and scanning services. It is designed for acquisition, analysis, edit, review, report and storage of all ECG and multi-parameter data. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), acute MI, ventricular hypertrophy, abnormal ST-T changes, lethal arrhythmias, and common rhythm abnormalities. TM eCloud ECG Analysis System can analyze recordings performed on newborns, children, and adults. TM eCloud ECG Analysis System's interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG that may be detected. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The TM eCloud ECG Analysis System consists of a (1) server-side, application Platform as a Service (PaaS) cloud based system, a (2) desktop client-side application, and (3) a web-based Physician Portal website. The (1) server-side, application PaaS component collects, stores, performs arrhythmia analysis on ECG uploads, and transfers data to and from the client-side application. The (2) desktop client-side application is a workstation system which allows technicians to review ECG, edit the analysis results produced by the (1) server-side, application PaaS component, and generate reports for the ECG study. The edited results and reports are uploaded to the (1) server-side, application PaaS component. It also allows notifications and updates to (3) Physician Portal website. The TM eCloud ECG Analysis System is capable of processing and performing arrhythmia analysis on ten seconds to 60 days of recorded ECG from one to 12 channels. The system is designed to be compatible with any stationary or ambulatory ECG device having the ability to export ECG. Typical compatible devices interfaces include Cardiac Mobile Telemetry, Event recorders, and Holter recorders but is not limited to a particular ECG device. ECG interfaces from desperate devices are translated by Telemed Adapters which convert proprietary formats to the Physionet WFDB MIT format but vendors may choose to provide the Physionet WFDB directly and bypass the use of an adapter. The purpose of the TM eCloud ECG Analysis System is to determine if any irregular rhythms, irregular beats, conduction defects, or ST depression occurred during the recording or monitoring. A qualified physician can then use the results of the analysis report to determine what action needs to be taken to help the patient reduce or prevent the occurrence of these abnormalities. The users may upload ECG to the TM eCloud ECG Analysis System via a cellular network, REST web service, or FTP from any computer or cellular equipment. The system performs analysis on the uploaded ECG using the proprietary 12 Lead Diagnostic EKG Analysis Engine or proprietary algorithm Reduced Lead 1-7 lead Analysis Engine and downloads the results to the client. If detected, the ECG engine will report on the following arrhythmias: ventricular ectopy, atrial ectopy, pauses, heart block, junctional rhythms, hemiblock, LBBB, RBBB, ST anomalies, and prolonged QT. It will display up to 900 statements including atrial fibrillation, ventricular fibrillation/flutter, and WPW. The (2) client workstation software employs several screens to display the ECG data. These screens include: 5-Minute View, Hourly view, or Daily view, 8-Second View, Arrhythmias Only View, time and frequency domain HRV, ST changes, AF burden. All analyzed data is saved in a database. From there data can be organized into a report that can be printed on paper or distributed electronically. Although the analysis engine reports arrhythmias and abnormalities with a high rate of accuracy, all results need to be reviewed and/or edited by a qualified medical professional.

The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.

The Smartheart is a personal, hand-held battery powered. 12 lead ECG and rhythm strip device with Bluetooth connection. The Smartheart acquires ECG data via attached electrodes. The Smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.

The LogicScan 64 / LogicScan 128 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The applications are: cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic, peripheral vessel and musculo-skeletal (conventional and superficial). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

LogicScan 128 / LogicScan 64 color diagnostic systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. LogicScan 128 / LogicScan 64 is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 12 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. USB 2.0 connection between the beamformer and PC is a novel feature for ultrasound systems. The LogicScan 128 / LogicScan 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the LogicScan 128 / LogicScan 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the LogicScan 128 / LogicScan 64. All sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the LogicScan 128 / LogicScan 64. Software able to reside in a Windows-based PC. The LogicScan 128 / LogicScan 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 12MHz probes). Two probes can work simultaneously for LogicScan 128 2Z modifications.

The TMC Health Monitor is intended to facilitate monitoring and transmission to a remote server of certain physiological parameters relevant to the remote management of health status and chronic disease conditions. The TMC Health Monitor is a system that provides: - Monitoring and display of vital signs/health parameters. - Management and scheduling of clinical measurements and questionnaires. - A web connection to patient health information. - Reporting to clinicians and allied health workers. The device has been designed to provide the user with information to assist with an appropriate treatment program or further investigation.

The TeleMedCare Health Monitor is designed to be used in the home or community setting to enable remote care management of patients with chronic illness. The TeleMedCare Health Monitor is an ergonomic design table top device with a touch screen and associated measurement components that may be integral or connected to it wirelessly or by cable. After measurements are recorded, the data is viewed and stored on the device then automatically transmitted via telephone modem or local area network (LAN) to a secure remote server. This data is then able to be viewed remotely over the web by the user's health care professional to assist them with chronic care management. Access to information stored and processed by the device is by means of password protection, encryption and use of collocated secure servers. The device also provides a means of messaging and video teleconferencing between the patient and carer to discuss their health and treatment. Questionnaires may also be configured by the carer to gauge other aspects of a patients well being. TeleMedCare software, captures, stores and transmits health data and access controlled carer's may set upper and lower limits to allow notification to them when these limits are exceeded to review health care management. The device however does not offer critical care or emergency support and requires professional medical interpretation for treatment of prescribed users. The System has functionality and devices to record, store and transmit data for body blood pressure, glucose and oximetry, heart rate (ECG), lung function (Spirometry), body temperature and weight. Power to the device is supplied by a medical grade power supply delivering 12 volts D.C to the system via a cable plugged into the back of the unit along with connection to tethered external measurement modules and the internet. The TeleMedCare Health Monitor has been tested and complies with international standards for electrical and electrocardiograph safety, electromagnetic compatibility and telecommunication standards.

Echo Blaster 128 / Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid and testicles), cephalic (neonatal and adult), musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see ch.1.3). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

Echo Blaster 128 / Echo Blaster 64 systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. Echo Blaster 128 / Echo Blaster 64 system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 10 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed. The Echo Blaster 128 / Echo Blaster 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Echo Blaster 128 / Echo Blaster 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the Echo Blaster 128 / Echo Blaster 64. All Sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave software was especially designed for the Echo Blaster 128 / Echo Blaster 64. Software able to reside in a Windows-based PC. The Echo Blaster 128 / Echo Blaster 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 10MHz probes can work simultaneously for Echo Blaster 128 2Z modifications.

The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical and clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals. Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: Skipped beats Pounding heart (palpitations) History of arrhythmia The clue medical and cluc medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.

The clue medical is an handheld battery operated single-channel ECG recorder featuring four fixed electrodes on the back of the device, an ECG lead connector, an IrDA and a Bluetooth interface and one single button to record and store up to ten ECG recordings with 30 seconds or two minutes duration. The stored ECG tests are processed into a printable Portable Document Format (PDF) that can be transmitted two ways. The PDF can be transmitted via IrDA or Bluetooth to an IrDa or Bluetooth capable local PC or printer. If the receiving device is not IrDa or Bluetooth capable, an optional IrDA USB stick is provided with the clue medical. The PDF file can then be saved, sent, displayed or printed. Alternatively, the PDF can be transmitted via a Bluetooth capable cell phone directly to the Telovital server for storage. The device requires that a user is mentally and physically capable of reading and understanding the Patient Operating Instructions. The patient must also be physically capable of pressing the record button and holding the device to his/her chest for an adequate reading. The clue medical BASIC is identical to the clue medical in design. The only difference is that the clue medical BASIC does not provide the added capability of sending the ECG data via cell phone directly to the Telovital server, it is only capable of transmission to a local PC or printer. The purpose of this Special 510(k) is to modify the method of wireless data transmission for both the clue medical and clue medical BASIC to include Bluetooth technology.

The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals. Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: Skipped beats Pounding heart (palpitations) History of arrhythmia The clue medical and clue medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.

The clue medical is an handheld battery operated single-channel ECG recorder featuring four fixed electrodes on the back of the device, an ECG lead connector, an IrDA interface and one single button to record and store up to ten ECG recordings with 30 seconds or two minutes duration. The stored ECG tests are processed into a printable Portable Document Format (pdf) that can be transmitted two ways. The pdf can be transmitted via IrDA to an IrDA capable local PC or printer. If the receiving device is not IrDA capable, an optional IrDA USB stick is provided with the clue medical. The pdf file can then be saved, sent, displayed or printed. Alternatively, the pdf can be transmitted via an IrDA capable cell phone directly to the Telovital server for storage. The clue medical BASIC is identical to the clue medical in design. The only difference is that the clue medical BASIC does not provide the added capability of sending the ECG data via cell phone directly to the Telovital server, it is only capable of IrDA transmission to a local PC or printer.