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510(k) Data Aggregation
K Number
K072473Device Name
CHASE MR SYSTEM
Manufacturer
Date Cleared
2007-12-10
(97 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
CHASE MEDICAL, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K062031Device Name
CHASE CARDIAC ANALYSIS SYSTEM
Manufacturer
Date Cleared
2006-09-27
(71 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CHASE MEDICAL, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from digital images acquired from a variety of imaging modalities including: magnetic resonance, computed tomography. This information is presented as both an interactive 3D model and as text reports. The System is designed to assist the analysis of coronary vessels, provide semi-automatic segmentation of cardiac structure and automatic calculation of anatomical and functional parameters. This information, when internreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.
Device Description
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