VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Primary DI

09120117253005

Basic UDI-DI Code

9120117253005S6

Reference

0202

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

piur imaging GmbH

The PIUR tUS inside serves as a non-invasive, transient and active medical device that is intended to support the user with the examination of thyroid and thyroid nodules, by providing 3D information. The 2D ultrasound images, acquired by a compatible third-party ultrasound device and position data, generated by the system-integrated PIUR Sensor, are the basis for 3D image reconstruction. The PIUR tUS inside consists of software and hardware components, including the PIUR Sensor and PIUR Bracket. The PIUR tUS inside acts as part of the diagnostic chain only and must not be used as a sole source for treatment decisions. PIUR tUS inside 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).