FDA Registration
Active
🇨🇦 Canada
Synthesis "VISION" viewer
Reg #: 3032579549
·
FEI: 3032579549
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SYNTHESIS HEALTH INTELLIGENCE INC.
- Registration Number
- 3032579549
- FEI Number
- 3032579549
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 22420 Dewdney Trunk Rd, Suite 300
- City
- Maple Ridge British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K240724
Owner / Operator
- Firm Name
- Synthesis Health Intelligence Inc.
- Operator Number
- 10091358
- Address
- 22420 Dewdney Trunk Rd, Suite 300
- City
- Maple Ridge
- State
- British Columbia
- Postal Code
- V2X 3J5
- Country
- CA
- Correspondent
- Baljinder Singh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-09-04 |
Proprietary Names
Synthesis "VISION" viewer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device