# K213480: 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Biomedical GmbH
- Decided: Feb 1, 2023 after 460 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: 3 generations back to K970852 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102748: 31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3T, Rapid Biomedical GmbH (2011) Summary page 6.

## Indications for use
The Head Coil is indicated for use as diagnostic device extension for a Philips, Siemens or GE 3.0 T MR system to provide cross-sectional 1H and/or any X nucleus images, spectroscopic images and/or spectra in any orientation of the internal structure of the head of the patient. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K213480
Methodology: https://510kreport.com/methodology