# K031517: Zargis Acoustic Cardioscan

- Pathway: 510(k) (Traditional)
- Applicant: Zargis Medical Corp.
- Decided: May 26, 2004 after 377 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: 4 generations back to K930806 (1994). 8 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031182: Eli 200+ Audicor, Mortara Instrument, Inc. (2003). Cleared while this submission was under review Summary page 1.
- K010949: 2010 Plus Holter for Windows, Agilent Technologies (2001) Summary page 1.

## Most influential descendants
- K060197: Zargis Acoustic Cardioscan (Zac), Model Zac 6.28 (2006), 15 descendants of its own
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own
- K052283: Heart STG System and Software (2005), 11 descendants of its own
- K121617: Sensicardiac (2012), 10 descendants of its own

## Indications for use
The Zargis Acoustic Cardioscan,(ZAC), 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 SI, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

Source page: https://510kreport.com/device/K031517
Methodology: https://510kreport.com/methodology