IMRIS iMRI 3T V
FDA 510(k) clearance K212367 · decided 2021-08-23
Clearance details
- K-number
- K212367
- Device name
- IMRIS iMRI 3T V
- Applicant
- Deerfield Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-30
- Decision date
- 2021-08-23
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Minnetonka, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla M recall (Z-0161-2026) | IMPRIS Imaging Inc | 2025-10-28 |
| IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra recall (Z-0162-2026) | IMPRIS Imaging Inc | 2025-10-28 |
| IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA recall (Z-0163-2026) | IMPRIS Imaging Inc | 2025-10-28 |
| IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, recall (Z-0164-2026) | IMPRIS Imaging Inc | 2025-10-28 |