# K060401: Medrad 3.0T Ecoil Imaging System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Mar 15, 2006 after 28 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053042: Medrad 1.5T Pelvic Imaging System Interface Device, Medrad, Inc. (2005) Summary page 1.
- K051349: 3.0T Prostate Imaging System, Medrad, Inc. (2005)

## Most influential descendants
- K191539: 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support (2020), 0 descendants of its own

## Indications for use
The eCoil Imaging System for the GE 3.01 family of 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 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 3.01 disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K060401
Methodology: https://510kreport.com/methodology