# K083309: Zargis Acoustic Cardioscan, Version 9.33

- Pathway: 510(k) (Special)
- Applicant: Zargis Medical Corp.
- Decided: Feb 13, 2009 after 95 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: 7 generations back to K910772 (1991). 38 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 53 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.
- K042128: Modification to Zargis Acoustic Cardioscan (Zac), Zargis Medical Corp. (2004) Summary page 1.
- K060197: Zargis Acoustic Cardioscan (Zac), Model Zac 6.28, Zargis Medical Corp. (2006) Summary page 1.
- K072137: Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZB, Avita Corporation (2007) Summary page 1.
- K063044: Cardiobelt Electrode Belt, Monebo Technologies, Inc. (2007) Summary page 1.
- K043359: 4100 Patient Oximeter Module, Nonin Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K110704: SENSI (2011), 13 descendants of its own
- 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

## 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 S1, 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/K083309
Methodology: https://510kreport.com/methodology