Summary for ARTG Entry:
IQ Medical - Corneal topography system
ARTG entry for
Medical Device Included Class IIa
2 / 86 Mary Street,UNLEY, SA, 5061
ARTG Start Date
Medical Device Class IIa
- 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.
Den Haag, , 35 2514 HD
1. Corneal topography system
Single Device Product
18038 Corneal topography system
An assembly of ophthalmic devices consisting of a line-powered diode laser that uses a solid as a
substrate, a videokeratoscope for imaging and application software for installation in an included computer
workstation, for image processing and analysis. This device is used to evaluate the curvature of the
cornea, by measuring the curvature and concentricity of the corneal surface, in preparation and planning
of Ophthalmic surgical procedures.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 07:53:06 AEDT
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