Zargis Acoustic Cardioscan

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K031517 ↗

FDA Product Code

DQD

Device Class

Class II

Regulation

21 CFR Part 870.1875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Zargis Acoustic Cardioscan, Version 9.33

  Class II

  FDA 510(k) K083309 Active Cleared 13 Feb 2009

• Signal

  Class II

  FDA 510(k) K090493 Active Cleared 7 Aug 2009

• Zargis Acoustic Cardioscan (Zac), Model Zac 6.28

  Class II

  FDA 510(k) K060197 Active Cleared 29 Mar 2006

• Modification to Zargis Acoustic Cardioscan (ZAC)

  Class II

  FDA 510(k) K042128 Active Cleared 8 Sep 2004

• What is the Zargis Acoustic Cardioscan intended to do?

  The Zargis Acoustic Cardioscan is an electronic auscultatory device intended to provide support to the physician in the evaluation of heart sounds in patients. It is designed to support physicians in analyzing cardiac sounds for the identification and classification of suspected murmurs.

• How is the Zargis Acoustic Cardioscan supplied and used?

  The device connects wirelessly to the Bluetooth-enabled Littmann Model 3200 stethoscope and is supplied as part of a system that includes the Zargis StethAssist software. It is not described as sterile, single-use, or reusable in the provided data, so no claims about sterility or reuse can be made.

• What regulatory pathway was used for the Zargis Acoustic Cardioscan?

  The device received FDA 510(k) clearance under K031517 and is classified as a Class II electronic stethoscope under regulation number 870.1875. The clearance type is Traditional, and the decision was based on a finding of Substantial Equivalence.

• What classification and product code apply to the Zargis Acoustic Cardioscan?

  The device is classified as a Class II electronic stethoscope under regulation number 870.1875 and has the product code DQD. It is categorized under the Cardiovascular medical specialty, as indicated in the openfda data and advisory committee description.