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510(k) Data Aggregation

    K Number
    K252474
    Device Name
    Withings BeamO (SCT02)
    Manufacturer
    Withings
    Date Cleared
    2025-11-10

    (96 days)

    Product Code
    DPS,DQD,SDV
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K170874,K130921,K160544,K181612
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Withings BeamO is intended to record, display (when prescribed or used under the care of a physician), store, and transfer single-channel electrocardiogram (ECG) rhythms. It is indicated for use with individuals 22 years and older.

    Withings BeamO is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages.

    Withings BeamO is also an electronic stethoscope that enables the recording and transmission of auscultation sound data. Withings BeamO is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages. The electronic stethoscope is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

    Device Description

    Withings BeamO, model name SCT02, is a multi-function handheld battery powered device with ECG, stethoscope, temperature capabilities. Withings BeamO can record a 1-lead ECG using two stainless steel electrodes. It analyzes the data collected by the integrated two stainless steel electrodes to generate an one-lead ECG waveform and provides the ECG recording to the user for a given 30 second measurement.

    Withings BeamO is also a contactless thermometer that can measure body temperature in adjusted mode.

    Withings BeamO is also a digital stethoscope that can be used to auscultate heart and lung sounds. The sensor generates an electric charge when subjected to mechanical vibrations. The charge variations are amplified and digitized by an audio codec. Sound filters are applied to the resulting sound wave in order to listen to the patient's heart and lung sounds with clarity.

    Withings BeamO consists of hardware and embedded software. Withings BeamO works in conjunction with a companion software on the Withings App. Withings BeamO communicates with the companion software via Bluetooth Low Energy (BLE). The device measurement results and recordings are synchronized with the companion software using Wi-Fi/Cellular data via the Withings servers.

    Withings BeamO does not include ECG analysis or ECG-derived heart rate functionalities.

    AI/ML Overview

    N/A

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