Stethophone Pro

Stethophone Pro is an electronic stethoscope software application that runs on smartphones to capture, amplify, filter, and transmit heart and lung sounds for real-time or recorded listening. It is intended for use by healthcare professionals and, in OTC mode without access to automated analysis, by lay users for assessing chest sounds in clinical and nonclinical environments. The Rx-only version includes automated heart sound analysis with murmur detection and S1/S2 timing.

Stethophone Pro v3.6.0 is a standalone iOS smartphone application with identical acoustics algorithms and automated sound analysis as the cleared predicate Stethophone Pro K240901. It operates on the same iPhone models, performs sound processing with spectrogram and oscillogram visualization, and supports three audio filters (Bell, Diaphragm, Starling). The only modification is expansion of intended use to include OTC availability for lay users when automated analysis is not accessed.

Not stated in this summary.

All acoustic filtering algorithms and automated analysis capabilities remain entirely unchanged from the previously cleared K240901 and K231551 predicates, which were already validated and cleared by FDA. Since no modifications affected device performance, the acoustics and analysis components require no new testing. The modification is limited to indications for use—specifically adding OTC availability for lay users without access to automated heart sound analysis. This does not introduce different safety or effectiveness questions because the underlying technology, functionality, and performance characteristics are identical to the predicates, and lay users can perform basic sound capture and transmission just as the predicates allow.