# K212367: IMRIS iMRI 3T V

- Pathway: 510(k) (Traditional)
- Applicant: Deerfield Imaging, Inc.
- Decided: Aug 23, 2021 after 24 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071099 (2007). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133692: Imri 1.5T and Imri 3T S, Imris, Inc. (2014) Summary page 5.

## Most influential descendants
- K252239: InVision™ 3T Recharge Operating Suite (2025), 0 descendants of its own
- K240157: InVision™ 1.5 Surgical Theatre (2024), 0 descendants of its own

## Recalls of this device
- Sep 30, 2025 · Class I · Z-0162-2026: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist wi
- Sep 30, 2025 · Class I · Z-0161-2026: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist wi
- Sep 30, 2025 · Class I · Z-0163-2026: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist wi
- Sep 30, 2025 · Class I · Z-0164-2026: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist wi

## Indications for use
The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.

Source page: https://510kreport.com/device/K212367
Methodology: https://510kreport.com/methodology