Search Results
Found 1 results
510(k) Data Aggregation
K Number
K023759Device Name
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
Manufacturer
Date Cleared
2003-05-06
(179 days)
Product Code
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
SONOMEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 medical acoustic experts are indicated or desired.
Limitations on Intended Use: The CSA is not intended for use on a singular basis for delivery of health care, not as a standalone diagnostic aid for evaluation of cardiovascular conditions and pathologies for which other more suitable diagnostic tools or medical procedures are available or indicated.
Device Description
The Cardiovascular Sonospectrographic Analyzer (CSA) is a cardiovascular acoustic detection system. The CSA is a passive, non-invasive means of detecting, processing and displaying human physiologic acoustic data as an aide/adjunct to the clinician in diagnosing conditions. It is useable in all applications where clinicians have traditionally used the stethoscope. However, through the use of ultra-sensitive acoustic detection technology, digital signal processing and a Fast Fourier Transform (FFT), the CSA is able to detect, process and display physiologic acoustic signals from the human body that are as little as 1,000,000 times less than the peak acoustic energy level of a heart sound.
Ask a Question
Ask a specific question about this device
Page 1 of 1