VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
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Basic Information
- 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
Additional 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).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11069080 | VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE |
Available In Countries
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