Ultrasound system, imaging, ophthalmic

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Ellex Medical Pty Ltd

Klasse:

Class IIa

Fremstillet af:

Ellex Medical Pty Ltd 3-4 Second Avenue, Mawson Lakes, SA, 5095 Australia

Terapeutisk område:

11389 - Ultrasound system, imaging, ophthalmic

Terapeutiske indikationer:

This device is a diagnostic ophthalmic ultrasound instrument specifically designed to be used by ophthalmologists, sonographers or trained echographers in clinics or outpatient facilities in a hospital or surgery for imaging and diagnosis of ocular structures and pathologies. It is assumed that the operator is trained in the operation of the instrument and on the medical interpretation of ultrasonic images. The patient is unable to influence the operation of the device. This device is used for ophthalmic imaging when the following conditions are present or suspected: . cataracts; . retinal detachments (a separation of the retina from the middle coat of the eyeball); . orbital lesions; . tumours; . foreign bodies; . inflammation; . vascular irregularities.

Autorisation status:

A

Autorisation dato:

2011-12-02