Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)

Primary DI

10850011472177

Basic UDI-DI Code

B-10850011472177

Reference

BPX 30

Device Types

Latex Single use

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

DxTx Medical, Inc.

The DxTx eCoil probes are recommendedfor high-resolution magnetic resonanceimaging including spectroscopy, of theprostate and surrounding pelvic tissue,and are specifically designed for use withthe appropriate eCoil Interface Device.The one-time use, disposable eCoil probehas been designed to be inserted into thehuman rectum. The unique coil shapefacilitates immobilization and localization  UDI-DI data Product original manufacturer Market Information of the prostate by maximizing coverage ofand conforming to the natural shape ofthe anatomy while enabling easy andaccurate device positioning andorientation of the eCoil probe to theanatomy. The eCoil probe may beinserted by a trained healthcareprofessional, depending on state orcountry law, who has training in eCoilprobe insertion.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).