Search Results
Found 1 results
510(k) Data Aggregation
K Number
K051853Device Name
CARDIOSTREAM SONOAIM
Manufacturer
Date Cleared
2005-08-22
(45 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CARDIOSTREAM, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioStream SonoAim is intended for capturing, transporting, and reporting patient cardiac study data.
Device Description
The CardioStream SonoAim is a clinical assessment tool designed to automate the movement of clinical data through the clinical assessment process. The system is comprised of the following components: Data Harvester (DH) - Laptop (variations - desktop, pole-mounted LCD screens), Data Packager (DP) - Computer (tower), AIM Server - Archive and Image Manager - located at secure off-site data center. Data and images are captured in the clinical setting via an image capture device (DH), and a preliminary report is completed by the Sonographer. The preliminary report is immediately formatted (DP) and available on a secure webaccessed internet site. The physician with secure user name and password will then access/review the clinical images and preliminary report, and edit or add commentary as needed. The final report is then electronically signed and returned to the referring physician. The information is available on any web-accessible device.
Ask a Question
Ask a specific question about this device
Page 1 of 1