3.0T Ingenia Endorectal Coil Interface Device System (eCoil®)

Primary DI

00850011472101

Basic UDI-DI Code

0850011472989603019032S5

Reference

9896-030-19032

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

The two medical devices which comprise this system are (1) 3.0T Ingenia Endorectal Coil Interface Device (eCoil®), UDI-DI 00850011472095 (2) Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®), UDI-DI 00850011472170 (individual) or 10850011472177 (box of 5)

The purpose of the 3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) is for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue, with the combination of the 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) and the Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®). This system is designed to be used exclusively with the Philips 3.0T Ingenia MRI Scanner System.

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