# K133692: Imri 1.5T and Imri 3T S

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Feb 10, 2014 after 70 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 6 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K071099 (2007). 2 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K071099: Neuro II-SE, Models: or-DR-or, or-MB, Imris, Inc. (2007) Summary page 2.
- K083137: Neuro Iii-SV, Imris, Inc. (2008) Summary page 2.

## Most influential descendants
- K212367: IMRIS iMRI 3T V (2021), 2 descendants of its own
- 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
- Apr 4, 2018 · Class II · Z-1645-2018: The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control p
- Feb 10, 2016 · Class II · Z-1098-2016: Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

## Indications for use
The iMRI 1.5T A and 3T S are 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 iMRI 1.5T A and 3T S systems 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 iMRI 1ST A and 3T S MRI systems may also be used for imaging in a multi-room suite.

Source page: https://510kreport.com/device/K133692
Methodology: https://510kreport.com/methodology