# K083255: 16CH AI Breast Coils 1.5 T and 3 T

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Biomedical GmbH
- Decided: Nov 21, 2008 after 17 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: 1 generation back to K973630 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973630: CP Breast Array Coil/Magnetom Harmony/Symphony System, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.

## Most influential descendants
- K181948: 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil (2018), 0 descendants of its own

## Indications for use
The 16 Ch Al Breast Coil 1.5 T and the 16 Ch Al Breast Coil 3 T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast.

Source page: https://510kreport.com/device/K083255
Methodology: https://510kreport.com/methodology