# K983902: Field Effects Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Intermagnetics General Corp.
- Decided: Jan 7, 1999 after 65 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: 1 generation back to K943799 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963953: Imig-Mri, Imig-Mri Systems, LLC (1996) Summary page 2.
- K943799: Version 5 Operating System Software, Hitachi Medical Systems America, Inc. (1994) Summary page 2.

## Indications for use
The Field Effects MRI system produces cross-sectional images: Anatomical Region: General body anatomy, including head, spine, forso, and extremities Nucleus excited: 1H nuclei (Proton) Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including - spin-lattice relaxation time (T1) - spin-spin relaxation time (12) - density of nuclei (p) - flow velocity - chemical shift (3) Clinical use: Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis. RF Coils: Head - quadrature Cervical Spine - quadrature Lumbar Spine, Thoracic Spine, and Abdomen - quadrature Knee - linear Image Acquisition Spin Echo Gradient Echo (GE,RGE) Fast Spin Echo (FSE) Fast Dual Echo (FDE) 3D Fast Gradient Echo (3DGE, 3DRGE) Inversion Recovery with Fast Spin Echo (FSE STIR, FSE FLAIR)

Source page: https://510kreport.com/device/K983902
Methodology: https://510kreport.com/methodology