IMRIS iMRI 3T V— 510(k) K212367
Substantially EquivalentDeerfield Imaging, Inc.
FDA 510(k) clearance K212367 for IMRIS iMRI 3T V, Substantially Equivalent on 2021-08-23. Applicant: Deerfield Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Deerfield Imaging, Inc.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Recent devices under product code LNH
view allMore clearances from Deerfield Imaging, Inc.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K212367
K-number listed on FDA's recall record- Z-0161-2026 — IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
- Z-0162-2026 — IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
- Z-0163-2026 — IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
- Z-0164-2026 — IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212367.
Data sourced from openFDA. This site is unofficial and independent of the FDA.