Is this your brand? Sign in to claim ownership.
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 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iCT | iCT System | FDA UDI | Class II | Active |
| VISIUSmatrix | 119898-000 | FDA UDI | Class I | Active |
| Hfd100 | 119629-000 | FDA UDI | Class II | Active |
| iMRI 1.5T A | iMRI 1.5T A, OR-DR-OR | FDA UDI | Class II | Active |
| Starter Kit, 1.5T Flex Coil | 116768-000 | FDA UDI | Class II | Active |
| InVision™ 3T Recharge Operating Suite | P122181 | FDA UDI | Class II | Active |
| ORT400 Table | 119900-000 | FDA UDI | Class I | Active |
| Patient Support Board | 119900-003 | FDA UDI | Class II | Active |
| Horseshoe Headrest | 116961-000 | FDA UDI | Class I | Active |
| MR/X-ray HFD (HFD 200) | HFD 200 | FDA UDI | Class II | Active |
| HC150 - 1.5T Head Coil Lower Neuro II-S | HC150 Lower Coil | FDA UDI | Class II | Active |
| HFD100 Rocker Arm Accessory | HFD100 Rocker Arm Accessory | FDA UDI | Class II | Active |
| IMRISeye - InVision 1.5 Surgical Theatre | 120999-000 | FDA UDI | Class I | Active |
| IMRISmatrix 5.0 | P122310 | FDA UDI | Class I | Active |
| VISIUSmatrix | 115407-000 | FDA UDI | Class I | Active |
| iMRI 1.5T A | iMRI 1.5T A, OR-DR-OR | FDA UDI | Class II | Active |
| Hfd100 | 119695-000 | FDA UDI | Class II | Active |
| iMRX System | iMRX System AR-DR-AR | FDA UDI | Class II | Active |
| InSitu Coil, 1.5T | InSitu Coil, Open, 1.5T | FDA UDI | Class II | Active |
| iMRI 3T S | OR-DR-OR 116053-000 | FDA UDI | Class II | Active |
| VISIUSmatrix | Application Platform 4.0- KIT | FDA UDI | Class I | Active |
| Hfd100 | 119630-000 | FDA UDI | Class II | Active |
| VISIUSeye | 117535-000 | FDA UDI | Class I | Active |
| ORT100 Table | ORT100 | FDA UDI | Class I | Active |
| VISIUSeye | 117533-000 | FDA UDI | Class I | Active |
| iMRI 1.5T A | iMRI 1.5T A, OR-DR | FDA UDI | Class II | Active |
| ORT300 Table | ORT300 | FDA UDI | Class I | Active |
| ORT 400 (Trumpf TruSystem 7500 MR Neuro) table | MR Neuro Accessory Adaptor | FDA UDI | Class I | Active |
| InVision™ 1.5T Operating Suite | 121111-000 | FDA UDI | Class II | Active |
| IMRISmatrix 5.0 | P122309 | FDA UDI | Class I | Active |
| HC150 - 1.5T Head Coil Lower Assy | HC150 Lower Assy | FDA UDI | Class II | Active |
| VISIUSeye | 120029-000 | FDA UDI | Class I | Active |
| VISIUSmatrix | Application Platform 4.0 2-Room | FDA UDI | Class I | Active |
| MR/X-ray HFD (HFD 200) | 113010-600 | FDA UDI | Class II | Active |
| VISIUSmatrix | 120086-000 | FDA UDI | Class I | Active |
| HC300- 3T Head Coil Upper Assy | HC300 Upper Assy | FDA UDI | Class II | Active |
| Headboard Assembly | 118714-000 | FDA UDI | Class II | Active |
| InVision™ 3T Recharge Operating Suite | K252239 | FDA 510(k) | Class II | Active |
| Horseshoe Headrest | 116668-000 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |