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Sign in to claim this brandIMRIS Imaging, Inc.
United States·US-MF-000041458
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1230, Chaska Creek Way, Chaska, United States
- Website
- www.imris.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Sanjay Shah
- EUDAMED SRN
- US-MF-000041458
- FDA FEI Number
- 3010326005
- DUNS Number
- 079990922
Catalogue (89)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ORT 400 (Trumpf TruSystem 7500 MR) table | ORT 400 (Trumpf TruSystem 7500 MR) Control Panel Assy | FDA UDI | Class I | Active |
| InSitu Coil | InSitu Coil, Open, 1.5T Large | FDA UDI | Class II | Active |
| Horseshoe Headrest | Horseshoe Headrest HFD100 Assembly | FDA UDI | Class I | Active |
| HC300 -3T Head Coil Lower Assy | HC300 Lower Coil | FDA UDI | Class II | Active |
| iMRX System | Post Assy, 1.5T 16CH Cardiac Coil | FDA UDI | Class II | Active |
| iMRX System | POSTERIOR ASSY, 3T 16CH CARDIAC COIL | FDA UDI | Class II | Active |
| VISIUSmatrix | 120088-000 | FDA UDI | Class I | Active |
| Neuro III-SV iMRI System | Neuro III-SV iMRI System | FDA UDI | Class II | Active |
| ORT300 Table | ORT300 | FDA UDI | Class II | Active |
| IMRISeye | 120999-000 | FDA UDI | Class I | Active |
| VISIUSmatrix | Application Platform 4.0- 3 Room | FDA UDI | Class I | Active |
| HC150 - 1.5T Head Coil Lower | HC150 Lower Coil | FDA UDI | Class II | Active |
| HC150 - 1.5T Head Coil Upper Assy | HC150 Upper Assy | FDA UDI | Class II | Active |
| ORT 400 (Trumpf TruSystem 7500 MR) table | ORT 400 (Trumpf TruSystem 7500 MR) table | FDA UDI | Class II | Active |
| VISIUSmatrix | Application Platform 4.0 KIT | FDA UDI | Class I | Active |
| HC300- 3T Head Coil Upper Assy | HC300 Upper Assy | FDA UDI | Class II | Active |
| iMRX System | Ant Assy, 1.5T 16CH Cardiac Coil | FDA UDI | Class II | Active |
| VISIUSmatrix | 119408-000 | FDA UDI | Class I | Active |
| Patient Support Board | 119749-000 | FDA UDI | Class II | Active |
| iMRI 1.5T A | iMRI 1.5T A, OR-DR-OR | FDA UDI | Class II | Active |
| ORT200 Table | ORT200 | FDA UDI | Class II | Active |
| InVision 1.5 Surgical Theatre | 121111-000 | FDA UDI | Class II | Active |
| iMRI 3T S | OR-DR, 116118-000 | FDA UDI | Class II | Active |
| VISIUSeye | VISIUSeye iMRI 1.5T A and 3TS | FDA UDI | Class I | Active |
| Ort200 | 113821-000 | FDA UDI | Class I | Active |
| HC150 - 1.5T Head Coil Upper Assy | HC150 Upper Assy | FDA UDI | Class II | Active |
| HC150 - 1.5T Head Coil Lower Assy | HC150 Lower Assy | FDA UDI | Class II | Active |
| iMRI 3T S | OR-DR-OR 116117-000 | FDA UDI | Class II | Active |
| Head Fixation Device HFD100 | HFD100 | FDA UDI | Class II | Active |
| HC150 - 1.5T Head Coil Upper Assy Neuro II S | HC150 Upper Assy | FDA UDI | Class II | Active |
| ORT200 Table | ORT200 | FDA UDI | Class I | Active |
| iMRI 3T S | OR-DR 116119-000 | FDA UDI | Class II | Active |
| InSitu Coil | InSitu Coil, Open, 3T Large | FDA UDI | Class II | Active |
| Horseshoe Headrest | Horseshoe Headrest HFD200 Assembly | FDA UDI | Class I | Active |
| Neuro III-SV iMRI System | Neuro III-SV iMRI System | FDA UDI | Class II | Active |
| VISIUSeye | VISIUSeye iMRI 1.5T A and 3TS | FDA UDI | Class I | Active |
| InVision™ 3T Operating Suite | 120823-000 | FDA UDI | Class II | Active |
| InSitu Coil, 3T | InSitu Coil, Open 3T | FDA UDI | Class II | Active |
| MR/X-ray HFD (HFD 210) | HFD210 | FDA UDI | Class II | Active |
| Starter Kit, 3T Flex Coil | 116769-000 | FDA UDI | Class II | Active |
| iMRX System | ANTERIOR ASSY, 3T 16CH CARDIAC COIL | FDA UDI | Class II | Active |
| IMRIS iMRI 3T V | 120823-000 | FDA UDI | Class II | Active |
| VISIUSeye | 117532-000 | FDA UDI | Class I | Active |
| Head Fixation Device HFD100 | HFD100 | FDA UDI | Class II | Active |
| iMRX System | iMRX System AR-DR MR30RS | FDA UDI | Class II | Active |
| ORT100 Table | ORT100 | FDA UDI | Class II | Active |
| iMRX System | iMRX System AR-DR-OR | FDA UDI | Class II | Active |
| HC150 - 1.5T Head Coil Lower | HC150 Lower Coil | FDA UDI | Class II | Active |
| HC300 -3T Head Coil Lower Assy | HC300 Lower Coil | FDA UDI | Class II | Active |
| IMRISeye | 120783-000 | FDA UDI | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 8, 2025 | Z-1034-2026 | — | open, classified | Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury. |