MDA 0202

Organization name

piur imaging GmbH

SRN

AT-MF-000001067

Manufacturer status

Active

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• CW010

  The PIUR tUS Infinity system must not be used under the following conditions: On patients with open wounds or irritated skin and during surgery

Primary placement in Austria; available across 8 countries total.

Trade name

not provided

UDI-DI code

09120117251100

Basic UDI-DI

9120117251100RK

Reference / catalog number

MDA 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 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).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11069080VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE

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