Omniscient (o8t) remains committed to sharing information with our customers in a way that is truthful, non-misleading, factual, and unbiased and provides all information necessary for healthcare providers (HCPs) to interpret the strengths and weaknesses and validity and utility of the information in o8t communication, in compliance with FDA’s guidelines on Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses (SIUU) of Approved/Cleared Medical Products.
Medical literature distributed by Omniscient employees may reference unapproved uses of Quicktome. Such uses have not been approved by the FDA and the safety and effectiveness of Quicktome for such unapproved uses has not been established.
In some instances, publications have been written, edited, or contributed to by employees of or consultants of o8t. However, information shared will have been reviewed by o8t to be one of:
- well-controlled investigations,
- partially controlled studies,
- studies and objective trials without matched controls,
- well-documented case histories conducted by qualified experts, and
- reports of significant human experience with a marketed device
In other words, information which is generally scientifically sound or clinically relevant.
o8t strives to ensure that:
- The study, analysis, or underlying data or information is not suggested to represent larger or more-general experience with the medical product than it actually does.
- Information (e.g., excerpts, quotes, paraphrases, conclusions) is not presented out of context, without the information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the information.
- Representations or suggestions about the safety or effectiveness of the medical product for unapproved use(s) are not explicitly made out-of-line with the information and without an explicit attribution to the source and authors, editors, or other contributors.
- Statistical analyses or techniques are not employed to indicate clinical significance or validity of a finding not supported by the data or information.
- Tables or graphs or other presentational elements do not distort or misrepresent the relationships, trends, differences, or changes among the outcomes evaluated in the study.
Quicktome’s FDA-cleared intended use is for the display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, 3D visualization (MPR reconstructions and 3D volume rendering), and display of BOLD (blood oxygen level dependent) resting-state MRI scan studies. Modules are available for image processing, atlas-assisted visualization and segmentation, resting state analysis and visualization, and target export creation and selection, where an output can be generated for use by a system capable of reading DICOM image sets.
Quicktome is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white-matter tracts based on constrained spherical deconvolution methods and for the use of said maps to select and create exports. Quicktome can generate motor, language, and vision resting state fMRI correlation maps using task-analogous seeds.
Quicktome is contraindicated for:
- Quicktome is not intended for final interpretation in Full-field Digital Mammography.
- The software does not aid in the diagnosis of disease conditions as this step is assumed to be completed prior to planning and visualization.
- Surgical navigation or active guidance during surgical procedure is not part of Quicktome.
A copy of Quicktome’s 510(k) summary may be accessed here. Please review the Quicktome User Manual for a complete list of warnings. Labelling (such as the user manual or acquisition protocol) may be acquired through the Quicktome software, by contacting your sales representative, or by submitting the form below.
