# K252239: InVision™ 3T Recharge Operating Suite

- Pathway: 510(k) (Traditional)
- Applicant: Imris Imaging, Inc.
- Decided: Aug 6, 2025 after 20 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K071099 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212367: IMRIS iMRI 3T V, Deerfield Imaging, Inc. (2021) Summary page 5.

## Indications for use
The InVision™ 3T Recharge Operating Suite 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 InVision™ 3T Recharge Operating Suite may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The InVision™ 3T Recharge Operating Suite may also be used for imaging in a multi-room suite.

Source page: https://510kreport.com/device/K252239
Methodology: https://510kreport.com/methodology