FDA Registration
Active
🇺🇸 United States
InVision 1.5T Operating Suite
Reg #: 3010326005
·
FEI: 3010326005
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- IMRIS Imaging, Inc.
- Registration Number
- 3010326005
- FEI Number
- 3010326005
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1230 Chaska Creek Way Suite 100
- City
- Chaska
- State
- MN
- ZIP
- 55318
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240157
Owner / Operator
- Firm Name
- IMRIS Imaging, Inc.
- Operator Number
- 10050332
- Address
- 1230 Chaska Creek Way, Suite 100
- City
- Chaska
- State
- MN
- Postal Code
- 55318
- Country
- US
- Correspondent
- Sanjay Shah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2024-02-20 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2024-02-20 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2024-02-20 |
Proprietary Names
InVision 1.5T Operating Suite
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device