DEVICE: TumorSight Viz (00860011523901)
Device Identifier (DI) Information
TumorSight Viz
V1.1
In Commercial Distribution
Simbiosys, Inc.
V1.1
In Commercial Distribution
Simbiosys, Inc.
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:
1) Visualization (standard image viewing tools, MIPs, and reformats)
2) Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering)
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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57812 | Radiology DICOM image processing application software |
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QIH | Automated Radiological Image Processing Software |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
46c07933-b47b-47f3-a9a1-099e1de9d073
July 15, 2025
3
June 03, 2024
July 15, 2025
3
June 03, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 872 270 0085
support@simbiosys.com
support@simbiosys.com