TumorSight Viz

Basic Information

• Brand Name: TumorSight Viz
• Primary DI: 00860011523901
• Version / Model: V1.1
• Company Name: Simbiosys, Inc.
• Labeler DUNS: 080409441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-03
• Public Version: 3
• Public Version Date: 2025-07-15
• Public Version Status: Update
• Public Device Record Key: 46c07933-b47b-47f3-a9a1-099e1de9d073

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: 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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QIH	Automated Radiological Image Processing Software	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011523901	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]