# K091166: IMRX

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Sep 2, 2009 after 133 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: 7 generations back to K801623 (1980). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073290: Artis Zee and Zeego, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.
- K083137: Neuro Iii-SV, Imris, Inc. (2008) Summary page 2.
- K061916: Neuro II-SE, Models or-MB-DR and or-DR, Imris, Inc. (2006) Summary page 2.
- K071099: Neuro II-SE, Models: or-DR-or, or-MB, Imris, Inc. (2007) Summary page 2.

## Most influential descendants
- K103506: 1.5T Head Coil (HC150), 3T Head Coil (HC300) (2011), 0 descendants of its own

## Indications for use
iMRX is an integrated imaging system combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging. The iMRX system uses the Artis zee family of dedicated angiography systems for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the iMRX system include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography and whole body radiographic/fluoroscopic procedures. The iMRX system can also support the acquisition of position triggered imaging for spatial data synthesis. The iMRX system uses the IMRIS family of Intra-operative MRI systems indicated for use as a magnetic resonance diagnostic device (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the head and whole body. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The iMRX 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 iMRX system may also be used for imaging in a multi-room suite.

Source page: https://510kreport.com/device/K091166
Methodology: https://510kreport.com/methodology