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Found 3 results
510(k) Data Aggregation
K Number
K251766Device Name
TumorSight Viz
Manufacturer
SimBioSys, Inc.
Date Cleared
2025-07-08
(29 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SimBioSys, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K243189Device Name
TumorSight Viz
Manufacturer
SimBioSys, Inc.
Date Cleared
2024-10-25
(25 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SimBioSys, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).
TumorSight Viz also includes user-configurable features for visualizing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight Viz.
Device Description
TumorSight Viz is an image processing system designed to assist in the visualization and analysis of breast DCE-MRI studies.
TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application.
Available features support:
- . Visualization (standard image viewing tools, MIPs, and reformats)
- . Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering)
- . Communication and storage (DICOM import, retrieval, and study storage)
The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer.
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K Number
K231130Device Name
TumorSight Viz
Manufacturer
SimBioSys, Inc.
Date Cleared
2023-12-26
(250 days)
Product Code
QIH, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SimBioSys, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).
TumorSight Viz also includes user-configurable features for visualizing and analyzing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight Viz.
Device Description
TumorSight Viz is an image processing system designed to assist in the visualization and analysis of breast DCE-MRI studies.
TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application.
Available features support:
- Visualization (standard image viewing tools, MIPs, and reformats)
- Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering)
- Communication and storage (DICOM import, retrieval, and study storage)
The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer.
Ask a Question
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