Identity
- Trade Name
- TumorSight Viz FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- V1.1 FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011523901 FDA UDI
- FDA Product Code
- QIH FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
TumorSight Viz by SimBioSys, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SimBioSys, Inc.
Sources (1)
- FDA UDI 46c07933-b47b-47f3-a9a1-099e1de9d073 34 fields · synced May 31, 2026