Siemens 3.0T Endo Interface (eCoil®)

Primary DI

00850011472187

Basic UDI-DI Code

085001147208624855VM

Reference

8624855

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

DxTx Medical, Inc.

The 3.0T Siemens Prostate Imaging System (“the device”) is part of the Prostate Imaging Offerings from DxTx and is intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate gland and surrounding pelvic tissue. The disposable eCoil Endorectal Coil (eCoil) is intended for one time use and is specifically designed to be used with an appropriate interface device. The 3.0T Siemens Prostate Imaging System is intended for use with Siemens 3.0T Tim Trio scanner platforms only. Only trained healthcare professionals are intended to operate this device. The 3.0T Siemens Prostate Imaging System is comprised of the Siemens Interface Device and the 3.0T eCoil (eCoil).

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