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510(k) Data Aggregation
K Number
K111642Device Name
ONCO TRAC MODEL 1, 2, 4
Manufacturer
TRANSLATIONAL SCIENCES CORPORATION
Date Cleared
2011-11-18
(158 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
TRANSLATIONAL SCIENCES CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OncoTrac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI, measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report.
OncoTrac™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. OncoTrac™ does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function.
OncoTrac™ is not intended for use for mammography.
Device Description
OncoTrac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI.
OncoTracTM runs on either a native or virtualized Microsoft Windows platform. Available functions include communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI. measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report. The user controls these functions with a system of interactive menus and tools.
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