FDA Registration
Active
🇺🇸 United States
IMRIS Imaging, Inc.
Reg #: 3010326005
·
FEI: 3010326005
·
Expires 2026
Products
13
Proprietary Names
24
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- IMRIS Imaging, Inc.
- Registration Number
- 3010326005
- FEI Number
- 3010326005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1230 Chaska Creek Way Suite 100
- City
- Chaska
- State
- MN
- ZIP
- 55318
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130224
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 |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2015-11-04 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2015-11-04 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2015-11-04 |
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | Class 2 | Neurology | No | 2015-11-04 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2015-11-04 |
| Table, Radiologic | KXJ | Class 2 | Radiology | No | 2015-11-04 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2017-11-09 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2025-08-21 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2015-11-04 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2015-11-04 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2015-11-04 |
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 2015-11-04 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2015-11-04 |
Proprietary Names
iCT
IMRISeye
Neuro II-SE
MR/X-ray HFD , HFD 200/HFD210
HC150 and HC300 Coils
ORT200, ORT300
ORT 400 (TruSystem 7500 MR) Table and Accessories
iMRX System
InVision 3T Recharge Operating Suite
HFD100 Rocker Arm Accessory
InVision 3T Operating Suite
IMRIS iMRI 3T V
Neuro III-SV iMRI System
Neuro II-SE iMRI System
inSitu Coils
iMRI 1.5T A and iMRI 3T S
OR Tables model ORT100, ORT200, ORT300, T2X
VISIUSmatrix- 2.3, 2.4, 3 ,4
IMRISmatrix 5
VISIUSmatrix
VISIUSmatrix- 2, 2.4, 3 ,4
Horseshoe Headrest
InVision 1.5T Operating Suite
HFD100
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198