0202

Organization name

piur imaging GmbH

SRN

AT-MF-000001067

Manufacturer status

Active

Primary placement in Austria; available across 14 countries total.

Trade name

not provided

UDI-DI code

09120117253005

Basic UDI-DI

9120117253005S6

Reference / catalog number

0202

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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