Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Nuvasive (Aust/NZ) Pty Ltd - LessRay System - Workstation, diagnostic imaging, x-ray system
ARTG entry for
Medical Device Included Class 1
Nuvasive (Aust/NZ) Pty Ltd
PO Box 422, KEW EAST, VIC, 3102
ARTG Start Date
Medical Device Class 1
- 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
- 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.
7475 Lusk Boulevard
San Diego, CA, 92121
United States Of America
1 . LessRay System - Workstation, diagnostic imaging, x-ray system
Medical device system
40935 Workstation, diagnostic imaging, x-ray system
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.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 08:22:24 AEST
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