# K061916: Neuro II-SE, Models or-MB-DR and or-DR

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Aug 11, 2006 after 36 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Neuro II-S: named in the summary without a submission number
- (no number) Neuro II: named in the summary without a submission number
- (no number) Siemens Magnetom Espree: named in the summary without a submission number

## Most influential descendants
- K091166: IMRX (2009), 1 descendant of its own
- K103506: 1.5T Head Coil (HC150), 3T Head Coil (HC300) (2011), 0 descendants of its own

## Recalls of this device
- Feb 10, 2016 · Class II · Z-1098-2016: Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
- Oct 19, 2012 · Class II · Z-0428-2013: IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the 

## Indications for use
The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body. The Neuro Il-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. correspond to the distribution of protons exhibiting MR characteristics; 2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (12); and 3. display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Neuro I-SE may also be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such 'as anesthesia and patient monitoring equipment. The Neuro II-SE may also be used in a multi-room suite.

Source page: https://510kreport.com/device/K061916
Methodology: https://510kreport.com/methodology