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The AusculThing ACC software is a decision-support SW for the healthcare provider (the user) in the evaluation of patient heart sounds. The ACC is used to record, display, and analyze acoustic signals of the heart recorded by means of an electronic stethoscope. It is intended for use on adult and pediatric patients. The automated analysis will categorize heart sounds as either "abnormal" if any heart murmur of any intensity is identified in any position across the precordium, or "normal" if either no murmurs or benign murmurs are identified. ACC is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretation offered by the software is only significant when used in conjunction with physician over-read and including all other relevant patient data. The device is intended for Rx use only. The AusculThing ACC shall be used together with Thinklabs One electronic stethoscope.

AusculThing ACC is a decision support SW that collects heart sounds from adult and pediatric patients. The ACC software receives the data using a Thinklabs One electronic stethoscope. The SW is running on a mobile device, where the electronic stethoscope is connected to. The SW guides the user how relevant heart sound recordings should be obtained from different parts of the body. After recording, the ACC analyzes the recordings in conjunction automatically using an AI -based algorithm, which is trained using a proprietary echocardiogram validated high-quality data database. The basic functionality of the ACC SW is to give a user an instant, automated, analysis of the patient under evaluation and differentiate between normal and pathological sounds. For the abnormal heart sounds, the ACC delivers information on suspected murmurs. The ACC software is a SW that allows a user to upload heart sounds/phonocardiogram (PCG) data to the device for analysis and visualization. The AusculThing ACC Mobile App runs on a mobile device. The app permits the electronic recording of heart sound signals via a compatible electronic stethoscope (Thinklabs One). The app also permits visual and acoustic playback of heart sounds in the mobile device. After analysis, results are returned to the user in the App. The Murmur detection algorithm is based on a neural network model that uses heart sounds to detect the presence of pathological heart sounds. The user can utilize the heart sound analysis results and the acoustic and visual representation of the heart sound recordings as decision support data in their decision-making process regarding the presence and type of a heart murmur.

The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur. eMurmur Heart AI is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.

To analyze heart sounds via the eMurmur Heart AI, a digital recording of a patient's heart sounds is required. Recordings are made using a supported digital stethoscope, connected to a front-end client like, e.g., the eMurmur app or the eMurmur web portal. The recorded auscultation data are transmitted from the front-end client to the eMurmur backend, which hosts the eMurmur Heart Al. After analysis by the eMurmur Heart Al, the results of the analysis are returned to the front-end client where they are displayed to the user. The user can utilize the eMurmur Heart AI results to support their decision-making process regarding the potential presence and type of a heart murmur. eMurmur is a non-medical device software platform which includes the eMurmur backend, eMurmur apps and eMurmur web portal. The platform is used to stream, record, display. replay, and store auscultation data, recorded by means of supported digital stethoscopes. The eMurmur software platform has functions subject to FDA premarket review, i.e., eMurmur Heart AI, as well as functions that are not subject to FDA premarket review. For this application. FDA assessed those functions only to the extent that they could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.

The Stethee™ Pro 1 is an electronic stethoscope intended for screening and medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective frequencies. It can be used on any person undergoing a physical assessment. Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable recording, playback, visualization, analysis, management and reporting of patient samples, and sharing this data with other authorized users.

The Stethee Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment. The Stethee Pro 1 consists of hardware and embedded software which controls all of the various features found in the device, such as sound capture, digital signal processing, volume control, haptic feedback for user, LED display ring, and wireless data transfer (via Bluetooth®). No patient data is stored on the Stethee Pro 1 device itself. After amplification and filtering of the sounds detected, Stethee Pro 1 transfers the sounds to the User's ears via any Bluetooth® connected headphones, or by wired headphones connected to Stethee Pro 1 using an AUX adaptor at the device's USB port. The Stethee Pro 1 also includes features that permit it to stream sounds to a peripheral smart device (e.g., mobile phone) as an audio buffer to a smart device (iOS or Android) via a Bluetooth® connection. The audio buffer is handled on the smart device by a separate standalone software application called the Stethee Pro Software System. Stethee Pro Software System (SPS) is a series of software applications (Stethee Pro Mobile Applications and the Stethee Pro Central Web Application) that work with the Stethee Pro 1 electronic stethoscope. Stethee Pro Software System is supported by M3DICINE's proprietary software platform M3DICINE Cloud Services (MCS) which provides various services including database, security, and core business logic services so that services for data sharing and multiple sign-ins from multiple devices can be implemented.

HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running. The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision. Caution: The sale of this device is restricted to licensed clinicians or entities referred to by a licensed clinician. It is intended for use by a licensed clinician only.

HD Steth is an electronic audio-visual stethoscope with integrated electrodes for electrocardiogram (ECG or EKG) rhythm. HD Steth is designed to acquire heart sounds through a diaphragm and 1-lead EKG rhythm through three fixed electrodes integrated around the diaphragm. The device has 3 auscultation modes – Bell, Diaphragmand Lung (Wide). The EK G rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. Both the heart sounds or phonocardiogram (PCG) and the EKG rhythm are acquired simultaneously and can be visualized, recorded and replayed using an accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.

The Vivio System is indicated for low frequency (<200 Hz) or Bell Mode operation to acquire and transmit heart sound data to the tablet/UI (with Avicena App) for calculation of heart rate and display and playback of heart sounds (audio and visual). The Vivio System is intended to be used as part of a physical assessment of a patient by healthcare professionals for diagnostic decision support. It may be used for the detection and amplification of sounds from the heart and arteries with the use of selective frequencies. It can be used on any person undergoing a physical assessment.

The Vivio Unit is an electronic stethoscope containing a membrane, placed on the skin over the carotid artery, that is displaced due to vibrations produced by the arterial pulse waveform and heart sounds associated with the aortic valve opening and closing. An infrared light photo reflector transmits and detects light to/from the membrane and outputs a current relative to the detected light (or membrane movement). Sensor electronics inside the Vivio Unit generate a current to operate the sensor, read the current produced by the sensor and output a voltage relative to the current. Filter electronics condition the sensor signal, process the data and communicate the data to the tablet with the Avicena App. The Vivio Unit is powered by an internal, rechargeable battery.

The eMurmur ID software system is a decision support device for the healthcare provider (the user) in the evaluation of patient heart sounds. eMurmur ID is used to record, display, analyze, and store the acoustic signal of the heart, recorded by means of an electronic stethoscope. The automated analysis will identify specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and absence of a heart murmur. eMurmur ID is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur ID are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.

eMurmur ID is a software system comprised of the following components: 1. The eMurmur ID Backend, running on a server environment, hosts the eMurmur ID Heart Sound Analysis Algorithm, an encrypted database for archiving patient and user information, and an application programming interface (API) for communication with the web portal and mobile application. 2. The eMurmur ID Mobile App, which runs on a mobile device. The app permits the following activities: a. Electronic recording of heart sound signals via a compatible electronic stethoscope, the Littmann 3200 b. Visual and acoustic playback of heart and lung sounds c. Capturing patient information d. Transferring data to and from the eMurmur ID backend through a secure connection e. Displaying heart sound analysis results 3. The eMurmur ID Web Portal, which provides the following functionalities: a. Capturing and editing patient information b. Displaying and editing patient encounters including heart sound analysis results c. Visual and acoustic playback of heart and lung sounds d. Downloading reports (PDF) and heart and lung sound recordings e. Transferring data to and from the eMurmur ID backend through a secure connection The acquisition of the acoustic data is carried out by the FDA-cleared off-the-shelf electronic stethoscope Littmann 3200 by 3M (MN, USA) (K083903). For heart sounds to be analyzed by the heart sound analysis algorithm, a 20 second digital recording of the patient's heart sounds and the patient's date of birth are required. Heart sounds are recorded using the compatible, FDA-cleared, off-the-shelf electronic stethoscope Littmann 3200. The heart sounds are transmitted via Bluetooth to a mobile device running the eMurmur ID mobile app. The app then stores and sends the recorded data to the eMurmur ID backend for analysis. The results of the heart sound analysis are returned to the app within a few seconds, where they are displayed to the user together with the heart sound recording. The user can utilize the heart sound analysis results and the acoustic and visual representation of the heart sound recordings as decision support data in their decision-making process regarding the presence and type of a heart murmur.

The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.

The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.

The intended use of the device is to acquire and record the 3 different types of heart bio-signals (ECG, PCG, and MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting. The indication for use is as ... a. a Standard 12 Lead Diagnostic ECG b. an aid to identify events in the cardiac cycle c. an aid to detect S1 & S2 hearts sounds and murmurs. Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner.

The Cardio-TriTest v6.5 (CTT) is three devices in one; combining a 12-Lead Electrocardiograph (ECG), a 4 Lead Phonocardiograph and a 4 lead Mechanocardiograph. The device will acquire all three types of bio-signals during the same non-invasive test procedure. The three types of signals are synchronized and outputted on the same timeline making it easier for general practitioners to visually determine a patient's current heart health. The ECG component is a Standard 12-Lead ECG, conformant with EN IEC 60601-2-25 standards. The CTT v6.5 device uses approved Standard 12-Lead FDA/CE cables. The CTT includes 4 Kombi-Sensors that include combine PCG/MCG functionality. The PCG component consists of 4 electronic stethoscopes into one Phono recording device. PCG sensors are equipped with diaphragms and non-chill rings. The MCG component consists of 4 MCG recording devices integrated into the Kombi-Sensor housing (PCG and MCG in same Sensor Housing). The PCG and MCG signal verification can be found in Annex E - Signal Testing. The PCG and MCG sensors are housed in common sensor housing, Kombi-Sensor, this allows the Kombi-sensor of being positioned/located in one of the 4 standard auscultation points on the thoracic wall. The combined PCG/MCG sensors record their signals when positioned on the four primary auscultation points on the thoracic wall.

The Stethee™ Pro 1 is an electronic stethoscope intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment.

The M3DICINE Stethee™ Pro 1 is an electronic stethoscope that picks up sounds of the heart, arteries, veins, lungs and other internal organs. Stethee™ Pro 1 provides capability for auscultation in frequencies from 20-2000Hz. After amplification and filtering, the sounds are transferred to the user's ears via any Bluetooth connected headphones. The Stethee™ Pro 1 includes features that permit it to record and store sounds on a peripheral smart device (e.g., mobile phone) by transferring the sounds as an audio buffer to the smart device via a Bluetooth® connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App, to record, manage and replay the captured patient sounds on the smart device. Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's smart device and can use the audio file to calculate and display a simple Heart Rate. Stethee™ App does not direct or influence the performance of Stethee™ Pro 1. The Stethee™ Pro 1 device user interface includes a simple push down mechanism ("control knob") to start recording. It has a light-emitting diode (LED) display ring which indicates the device's status state (ON or OFF, charge status, and Bluetooth® synchronization status). The Stethee™ Pro 1 operates on a rechargeable certified 3.7V lithium ion polymer battery. The Stethee™ Pro 1 incorporates embedded software. The embedded software controls all the various features found in the Stethee™ Pro 1, such as sound capture, digital signal processing, volume control, LED display ring, and Bluetooth® transfer.

The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.

Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart and lung sounds. Steth IO attaches to the back of the smartphone and contains an acoustic wave guide that channels sound from the Steth IO chest piece to the smartphone's microphone, while also acting as a protective covering for the phone. The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram. The device is capable of recording sound and phonocardiogram data, allowing healthcare providers to capture biological sounds and send the data to other healthcare providers or for review at a later time. Steth IO is intended for use as a diagnostic aid, enabling the healthcare provider to identify sounds and any abnormalities that may be present.