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510(k) Data Aggregation
K Number
K080325Device Name
IGROK
Manufacturer
Date Cleared
2008-04-08
(62 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IGROK, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IGROK is a hardware/software system that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. Certain registration functions and analyses are only applicable in pelvic, head and neck areas. IGROK is not intended for mammography diagnosis.
Device Description
IGROK is a computer hardware and software system which is intended to facilitate Image-Guided Radiation Therapy (IGRT) by consolidating and organizing a wide array of data pertaining to a patient's course of external beam radiation therapy, and presenting this data, along with relevant analyses, so as to efficiently support typical IGRT review and decision-making tasks. The system functions as a radiation therapy-specific PACS, providing storage and visualization for DICOM diagnostic imaging, treatment plans, dose volumes, RT images, and structure set data. In addition, registration is provided between image volumes using both linear and non-linear techniques.
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