Search Results
Found 1 results
510(k) Data Aggregation
K Number
K101707Device Name
FULACCESS MODEL 1.0
Manufacturer
FULCRUM MEDICAL, INC
Date Cleared
2010-10-29
(134 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
FULCRUM MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. These files can be stored locally or on portable media (e.g. CD and DVD).
fulAccess is a stand-alone software package that assists users in the display, analysis, comparison and communication of medical imaging data from various sources. It allows the display, analysis, annotation, and communication of medical images. The intended users of fulAccess are trained medical professionals including physicians, nurses, physicists and other medical technologists. fulAccess is not intended for use in mammography.
Device Description
fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. These files can be stored locally or on portable media (e.g. CD and DVD).
fulAccess is a Windows application and will be used on recommended hardware that is provided by the company or the end user.
Ask a Question
Page 1 of 1