# K063342: Medrad Ecoil Imaging System for Philips

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Nov 30, 2006 after 24 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 K926571 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051349: 3.0T Prostate Imaging System, Medrad, Inc. (2005) Summary page 1.

## Indications for use
The eCoil Imaging System for Philips MRI scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K063342
Methodology: https://510kreport.com/methodology