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510(k) Data Aggregation
K Number
K073021Device Name
MULTI-SPECT
Manufacturer
Date Cleared
2007-11-06
(11 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
EAGLE HEART IMAGING, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Multi-SPECT is intended for use as an accessory to an dual headed nuclear medicine gamma camera (for example - the ADAC Vertex Dual Headed Nuclear Medicine Camera). It is to be used to perform static, dynamic and/or gated Single Photon Emission Computed Tomography clinical nuclear medicine images of the heart. It is indicated for use to produce images showing the location and distribution of radioisotopes in the human body for interpretation by a physician.
Device Description
The product consists of two multi-pinhole collimators attached to the two heads of a dual headed gamma camera (eg ADAC (now Philips) Vertex Gamma Camera). The collimators are designed to perform myocardial perfusion studies. Each collimator consists of a 2 x 3 array of pinholes. Each pinhole is focused on the patient's heart, such that the radioisotope distribution in the heart is seen from 18 different view points. This multiplicity of views allows for tomographic reconstruction of the radioisotope distribution in the heart. Acquisition is done in list-mode, retaining position, energy and patient physiological data. The raw listmode data is framed and corrected for scatter, then reconstructed into a three dimensional matrix. It can then be analyzed by previously cleared software packages (eg Emory Cardiac Toolbox™ - K040141).
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