# K123708: Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Paramed Medical Systems, Inc.
- Decided: Apr 10, 2013 after 128 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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: 2 generations back to K073362 (2008). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101295: Mropen, Paramed S.R.L. (2010) Summary page 2.

## Most influential descendants
- K151466: MrOpen (2015), 3 descendants of its own
- K190524: MRopen 0.5 T (2019), 2 descendants of its own
- K193116: MRopen EVO (2019), 1 descendant of its own
- K242258: MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (2024), 0 descendants of its own

## Indications for use
The intended use of the SPINE COIL is to enable the MrOpen K101295 systems designed by Paramed to perform MR scan of the human spine either in the conventional recumbent position or with the patient sitting or standing (weight-bearing). The SPINE COIL inherits the same limitations of the Tomograph. The SPINE COIL enables the MRif System to which it is applied to acquire images of the Spine in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful informnation.

Source page: https://510kreport.com/device/K123708
Methodology: https://510kreport.com/methodology