# K023759: Cardiovascular Sonospectrographic Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sonomedica
- Decided: May 6, 2003 after 179 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: 1 generation back to K963418 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963418: Transmedica Model 100 Digital Electronic Stethoscope, Transmedica, Inc. (1997) Summary page 1.

## Indications for use
The Cardiovascular Sonospectrographic Analyzer (CSA) is intended for use in health care environments and setting where conventional stethoscopes (both electronically augmented and non-augmented) and phonocardiographs are used by health care professionals for the auscultation, graphical representation, measurement and archiving of cardiovascular, pulmonary, and other such sounds, both normal and abnormal, as produced by the human body. The CSA is a medical instrument intended for use by, or at the direction of, a qualified health care professional as a diagnostic aid for the clinical assessment and discrimination of acoustic patterns relating to or caused by clinically significant pathologies and medical conditions as known, defined, or specified in standard medical auscultation/phonocardiographic reference textbooks, peer review journals, and medically approved auscultation training materials. The CSA is further intended for the monitoring of interventional or prophylactic therapies that are susceptible to the level of medical efficacy provided by CSA and as is clinically indicated at the discretion of the physician. The CSA is also intended for use in telemedical applications where secondary analysis and options by non-local medical acoustic experts are indicated or desired.

Source page: https://510kreport.com/device/K023759
Methodology: https://510kreport.com/methodology