Elekta Medical Linear Accelerator - Accelerator system, linear

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Elekta Pty Ltd

Class:

Class IIb

Manufactured by:

Elekta Solutions AB Kungstensgatan 18 Box 7593, Stockholm, SE-103 93 Sweden

Therapeutic area:

35159 - Accelerator system, linear

Therapeutic indications:

The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner. ? It is intended to assist a licensed practitioner in the delivery of EBRT to defined target volumes, whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions of standard dose fractions, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy ? SBRT; stereotactic ablative radiotherapy- SABR; stereotactic radio surgery ? SRS); in all areas of the body where such treatment is indicated. ? The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Paediatric patients with primary benign and malignant tumors, metastases (or secondaries), and functional indications.

Authorization status:

A

Authorization date:

2020-12-02