# K083137: Neuro Iii-SV

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Dec 16, 2008 after 54 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
3 of 7 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-SE: named in the summary without a submission number
- (no number) Neuro II-S: named in the summary without a submission number
- (no number) Siemens MAGNETOM Verio: named in the summary without a submission number

## Most influential descendants
- K133692: Imri 1.5T and Imri 3T S (2014), 3 descendants of its own
- K212367: IMRIS iMRI 3T V (2021), 2 descendants of its own
- K091166: IMRX (2009), 1 descendant 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
- 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 Neuro III-SV Intra-operative MRI system 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 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 Neuro III-SV 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 Neuro III-SV may also be used for imaging in a multi-room suite.

Source page: https://510kreport.com/device/K083137
Methodology: https://510kreport.com/methodology