# K181948: 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Biomedical GmbH
- Decided: Nov 16, 2018 after 119 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 K973630 (1997). 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)
- K083255: 16CH AI Breast Coils 1.5 T and 3 T, Rapid Biomedical GmbH (2008) Summary page 5.

## Indications for use
The 16Ch Diagnostic Breast Coils are indicated for use as diagnostic imaging device extensions for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K181948
Methodology: https://510kreport.com/methodology