LessRay System - Workstation, diagnostic imaging, x-ray system

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Nuvasive (Aust/NZ) Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339818

Public Summary

Summary for ARTG Entry:

339818

Nuvasive (Aust/NZ) Pty Ltd - LessRay System - Workstation, diagnostic imaging, x-ray system

ARTG entry for

Medical Device Included Class 1

Sponsor

Nuvasive (Aust/NZ) Pty Ltd

Postal Address

PO Box 422, KEW EAST, VIC, 3102

Australia

ARTG Start Date

20/07/2020

Product Category

Medical Device Class 1

Status

Active

Approval Area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2

(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for

relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;

and civil penalties may apply.

Manufacturers

Name

Address

Nuvasive Inc

7475 Lusk Boulevard

San Diego, CA, 92121

United States Of America

Products

1 . LessRay System - Workstation, diagnostic imaging, x-ray system

Product Type

Medical device system

Effective Date

20/07/2020

GMDN

40935 Workstation, diagnostic imaging, x-ray system

Intended Purpose

LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

LessRay is intended for use with a standard C-arm or fluoroscope during a surgical or interventional procedure. When used in

connection with the low-dose and/or pulse setting on the fluoroscope, the user may improve the quality (clarity, contrast, noise level,

and usability) of a noisy (low-quality) image. By using this system, some or much of the graininess of low-radiation dose images

may be eliminated, allowing for greater utility of low-dose imaging in the O.R. LessRay works by combining (or in some cases

alternating) the current image being taken with a prior "learned" image of the same anatomy. The initial image, taken at full radiation

dose settings, serves as the "baseline" to which images taken at lower dose radiation settings are compared to and enhanced.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 22.07.2020 at 08:22:24 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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