Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens

Primary DI

00850011472002

Basic UDI-DI Code

0850011472BPX30NG-SJ8

Reference

BPX 30 NG-S

Device Types

Latex Single use

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

DxTx Medical, Inc.

The DxTx Medical e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is a system of receive-only coils 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 in the male human anatomies. The purpose of the DxTx Medical e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is to provide interface and support functions to allow the use of 3.0T disposable e2Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device. The e2Coil probes are recommended for high-resolution magnetic resonance imaging of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e2Coil Interface Device. The one-time use, disposable e2Coil probe has been designed to be inserted into the human rectum. The unique coil shape facilitates immobilization and localization of the prostate by maximizing coverage of, and conforming to, the natural shape of the anatomy while enabling easy and accurate device positioning and orientation of the e2Coil probe to the anatomy. The e2Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e2Coil probe insertion.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).