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510(k) Data Aggregation
K Number
K180522Device Name
IGTFusion
Manufacturer
Date Cleared
2018-08-16
(170 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IGI Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IGTFusion is a stand-alone software product that provides the physician 3 means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, interventional radiology and other medical Specialties. IGTFusion is not intended for mammography diagnosis.
Device Description
The purpose of IGTFusion is to assist the user with the visual evaluation, comparison, and merging of information between anatomical and functional images from a single patient. The user needs to take into consideration the product's limitations and accuracy when integration from the registration results for final interpretation. IGTFusion does not replace the usual procedures for visual comparison of datasets by a user. Fusion images are intended to provide additional information to a user's existing workflow for patient evaluation.
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