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510(k) Data Aggregation
K Number
K970970Device Name
CARDIOMATCH
Manufacturer
Date Cleared
1997-06-13
(88 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
FOCUS MEDICAL SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cardiac Stress and Rest SPECT Imaging Processing Software is a diagnostic software program that quantitatively analyzes myocardial perfusion in patients injected with Cardiolite® (Tc Sestamibi) or Thallium following a rest/stress Single Photon Emission Computerized Tomography (SPECT) acquisition protocol.
Device Description
The program automatically determines the alignment parameters for the stress and rest reconstructed MPS SPECT images and, following operator venification of these parameters, performs a size and shape normalization to a template using a published and independently validated 3D image registration method. The normalized images are then compared to a normal distribution and the results of this comparison are used to generate a visual and quantitative representation of the extent and location of perfusion defects. Results are presented in the form of 3D representation of the normalized images including a visualization of the abnormalities as well as a table indicating the number. extent and location of abnormalities.
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