# K050132: Neuro II-S

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Magnetic Resonance Imaging Systems, Inc.
- Decided: Feb 15, 2005 after 25 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 K931544 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002964: Neuro II, Innovative Magnetic Resonance Imaging Systems, Inc. (2000) Summary page 2.
- K020991: Syngo MR 2002B, Siemens Medical Solutions USA, Inc. (2002) Summary page 2.
- K964626: Edge/Vista System Enhancement Package, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 2.
- (no number) Picker Large Joint Coil: named in the summary without a submission number

## Indications for use
The IMRIS Neuro 11-S MRI system is indicated for use for the whole body. The Neuro 1I-S 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 (TI) and spin-spin relaxation time (T2); 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 11-S 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.

Source page: https://510kreport.com/device/K050132
Methodology: https://510kreport.com/methodology