Combination diagnostic imaging system, PET/CT

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Philips Electronics Australia Ltd

Class:

Class IIb

Manufactured by:

Philips Medical Systems Nederland BV Veenpluis 4-6, PC Best, 5684 Netherlands

Therapeutic area:

45143 - Combination diagnostic imaging system, PET/CT

Therapeutic indications:

A diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic,and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Authorization status:

A

Authorization date:

2019-09-27