FDA Registration
Active
🇺🇸 United States
TumorSight Viz
Reg #: 3030598283
·
FEI: 3030598283
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SIMBIOSYS, INC.
- Registration Number
- 3030598283
- FEI Number
- 3030598283
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 320 N Sangamon Street, Suite 700
- City
- Chicago
- State
- IL
- ZIP
- 60607
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231130
Owner / Operator
- Firm Name
- SimBioSys, Inc.
- Operator Number
- 10090319
- Address
- 320 N Sangamon Street, Suite 700
- City
- Chicago
- State
- IL
- Postal Code
- 60607
- Country
- US
- Correspondent
- Tricia Carrigan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-03-12 |
Proprietary Names
TumorSight Viz
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device