TumorSight Viz

GUDID 00860011523901

TumorSight Viz is an image processing system designed to assist in the visualization and analysis, of breast DCE-MRI studies. TumorSight Viz reads DICOM magnetic resonance images. TumorSight Viz processes and displays the results on the TumorSight Viz 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) 3) Communication and storage (DICOM import, retrieval, and study storage) The TumorSight Viz system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer

Simbiosys, Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00860011523901
• NIH Device Record Key: 46c07933-b47b-47f3-a9a1-099e1de9d073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TumorSight Viz
• Version Model Number: V1.1
• Company DUNS: 080409441
• Company Name: Simbiosys, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com
• Phone: +1 872 270 0085
• Email: support@simbiosys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011523901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231130

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-11
• Device Publish Date: 2024-06-03