# K140252: 16 CH Multipurpose Coil Variety

- Pathway: 510(k) (Traditional)
- Applicant: Noras Rontgen-Und Medizintechnik GmbH
- Decided: May 8, 2014 after 97 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: 5 generations back to K971684 (1997). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083578: Noras CPC Multifunctional Coil, Noras Mri Products GmbH (2009) Summary page 4.
- K111673: 1.5T and 3T 8-Channel Medium General Purpose Flex Coil, Invivo Corporation (2011) Summary page 4.

## Indications for use
The intended use of the 16 Ch Multipurpose Coil Variety 1.5T and 3T is, in conjunction with a Magnetic Resonance Scanner. body imaging for diagnostic with a MRI system. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by atrained physician, these images provide information that can be useful in determining diagnosis. The outcome of this is diagnostic images of toes, feet, ankle, knee. inger, hand, wrist, elbow, shoulder, carotid ariery. inner ear and other pants of the body with similar structure can be taken.

Source page: https://510kreport.com/device/K140252
Methodology: https://510kreport.com/methodology