IMRI 1.5T AND IMRI 3T S
FDA 510(k) clearance K133692 · decided 2014-02-10
Clearance details
- K-number
- K133692
- Device name
- IMRI 1.5T AND IMRI 3T S
- Applicant
- Imris, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-02
- Decision date
- 2014-02-10
- Days to decision
- 70 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
+ Add to Predicate Builder ◉ Watch Imris
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |
| Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indic recall (Z-1098-2016) | Deerfield Imaging | 2016-03-11 |