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510(k) Data Aggregation
K Number
K222359Device Name
Quicktome Software Suite
Manufacturer
Omniscient Neurotechnology Pty Ltd (O8t)
Date Cleared
2023-05-30
(299 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Omniscient Neurotechnology Pty Ltd (O8t)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quicktome Software Suite is composed of a set of modules intended for 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, resting state analysis and visualization, and target export creation, 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 whitematter 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.
Typical users of Quicktome are medical professionals, including but not limited to surgeons, clinicians, and radiologists.
Device Description
Quicktome is a software-only, cloud-deployed, image processing package which can be used to perform DICOM image viewing, image processing, and analysis.
Quicktome can receive ("import") DICOM images from picture archiving and communication systems (PACS), acquired with MRI, including Diffusion Weighted Imaging (DWI) sequences, T1, T2, BOLD, and FLAIR images. Quicktome can also receive Resting State functional MRI (rs-fMRI) blood-oxygen-level-dependent (BOLD) datasets. Once received, Quicktome removes protected health information (PHI) and links the dataset to an encryption key, which is then used to relink the data back to the patient when the data is exported to hospital PACS or other DICOM device.
The software provides a workflow for a clinician to:
- . Select an image for planning and visualization,
- Validate image quality,
- Explore the available anatomical regions, network templates, tractography bundles, and ● parcellations,
- . Select regions of interest,
- . Display resting state fMRI (BOLD) correlation maps using task-analogous seeds for Motor, Vision and Language networks, and
- . Export black and white and color DICOMs for use in systems that can view DICOM images.
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K Number
K203518Device Name
Quicktome
Manufacturer
Omniscient Neurotechnology Pty Ltd (o8t)
Date Cleared
2021-03-09
(98 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Omniscient Neurotechnology Pty Ltd (o8t)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quicktome is intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, and 3D visualization (MPR reconstructions and 3D volume rendering). Modules are available for image processing and atlas-assisted visualization and segmentation, 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.
Typical users of Quicktome are medical professionals, including but not limited to surgeons and radiologists.
Device Description
Quicktome is a software-only, cloud-deployed, image processing package which can be used to perform DICOM image viewing, image processing, and analysis.
Quicktome can retrieve DICOM images from picture archiving and communication systems (PACS), acquired with MRI, including Diffusion Weighted Imaging (DWI) sequences, T1, T2, and FLAIR images. Once retrieved, Quicktome removes protected health information (PHI) and links the dataset to an encryption key, which is then used to relink the data back to the patient when the data is exported to the hospital PACS. Processing is performed on the anonymized dataset in the cloud. Clinicians are served the processed output for planning and visualization on their local machine.
The software provides a workflow for a clinician to:
- Select a patient case for planning and visualization,
- Confirm image quality,
- Explore anatomical regions, network templates, tractography bundles, and parcellations,
- Create and edit regions of interest, and
- Export objects of interest in DICOM format for use in systems that can view DICOM images.
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