# K991243: NORMA 10

- Pathway: 510(k) (Traditional)
- Applicant: Odin Technologies, Ltd.
- Decided: Jun 18, 1999 after 67 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 K911642 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963186: ORTHO 8000, Inner Vision Mri, Ltd. (1996) Summary page 3.
- K911642: MRP-5000 and MRP-7000 Multiplanar Reconstruction, Hitachi Medical Systems America, Inc. (1991) Summary page 3.

## Most influential descendants
- K020601: Flexicoil - Malleable Receive-Only Surface Coil (2002), 0 descendants of its own

## Indications for use
The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis. • Anatomical regions: extremities and selected sections of the head. • Nuclei excited: H-1 • Diagnostic uses: T1, T2, T2* and density weighted imaging.

Source page: https://510kreport.com/device/K991243
Methodology: https://510kreport.com/methodology