VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE

Primary DI

09120117251100

Basic UDI-DI Code

9120117251100RK

Reference

MDA 0202

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

piur imaging GmbH

The PIUR tUS Infinity system serves as a non-invasive, transient and active medical device that is intended to support on issues concerning diagnosis of various diseases by providing 3D information generated from a sequence of external ultrasound images. The PIUR tUS Infinity acts as part of the diagnostic chain only and must not be used as a sole source for treatment decisions. 2D ultrasound images acquired by an ultrasound device that is not part of the product and position data of the system-integrated position tracking system are the basis for the 3D image reconstruction. This ultrasound device must be a medical device according to MDR 2017/745 with a valid CE-Label. PIUR tUS Infinity device is not intended for body contact (including skin, mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood).

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