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510(k) Data Aggregation
K Number
K990052Device Name
TEL-ECHO SYSTEM
Manufacturer
Date Cleared
1999-02-19
(43 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE MEDICAL SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tel-Echo System is intended to acquire echocardiographic images during a cardiac ultrasound exam and transfer them to another location for viewing. This system is intended for tele-echocardiography applications.
Device Description
The Tel-Echo System is designed specifically to transmit cardiac ultrasound (echocardiographic) exams over telephone lines for remote review. This application is usually referred to as tele-echocardiography.
A Tel-Echo System may send complete exams from a remote clinic to the main clinic. It may also send selected images to a physician's home or office for "on call" coverage. The Tel-Echo System acquires echocardiographic images in parallel with the VCR(Video Cassette Recorder) or other recording method. This VCR tape or equivalent digital media comprise the exam record and not the Tel-Echo system, which is for communication only.
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