Eu Mdd Eu Md Class 2a On The Market 🇺🇸 United States

Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)

DxTx Medical, Inc. · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
1
Countries
25
Notified Bodies
1

Basic Information

Primary DI
10850011472146
Basic UDI-DI Code
B-10850011472146
Reference
BPX 15
Device Types
Latex Single use
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
DxTx Medical, Inc.

Additional Description

The DxTx eCoil probes are recommended for high-resolution magnetic resonance imaging including spectroscopy, of the prostate and surrounding pelvic tissue, and are specifically designed for use with the appropriate eCoil Interface Device. The one-time use, disposable eCoil 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 eCoil probe to the anatomy. The eCoil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in eCoil probe insertion.

CND Nomenclature Codes

Code Description
Z1105018002 MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS

Certificates

Type Number
MDD Annex II (excluding section 4) 36594

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇸🇪 Sweden 🇸🇰 Slovakia 🇹🇷 Türkiye

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