# K052283: Heart STG System and Software

- Pathway: 510(k) (Traditional)
- Applicant: Stethographics, Inc.
- Decided: Dec 23, 2005 after 123 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930806 (1994). 9 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031517: Zargis Acoustic Cardioscan, Zargis Medical Corp. (2004) Summary page 1.

## Most influential descendants
- K121617: Sensicardiac (2012), 10 descendants of its own
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application (2013), 9 descendants of its own
- K181988: eMurmur ID (2019), 7 descendants of its own
- K192004: Eko Analysis Software (2020), 4 descendants of its own
- K213794: Eko Murmur Analysis Software (EMAS) (2022), 3 descendants of its own

## Indications for use
The Stethographics Heart STG System, is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients. The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include St, S2, and suspected systolic murmurs. The device is indicated for use in the clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It in not intended as a sole means of diagnosis. The interpretations of heart sounds offered by the Heart STG System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.

Source page: https://510kreport.com/device/K052283
Methodology: https://510kreport.com/methodology