# K191539: 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Biomedical GmbH
- Decided: Jan 31, 2020 after 235 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: 4 generations back to K926571 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060401: Medrad 3.0T Ecoil Imaging System, Medrad, Inc. (2006) Summary page 6.
- K053042: Medrad 1.5T Pelvic Imaging System Interface Device, Medrad, Inc. (2005) Summary page 6.

## Indications for use
The Endorectal Coil is 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, displaying the internal structure of the prostate. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K191539
Methodology: https://510kreport.com/methodology