GE Discovery™ MI Digital Ready

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

MAH:

GE HEALTHCARE PTE. LTD.

class:

Class C medical device

manufactured_by:

GE Medical Systems LLC

therapeutic_area:

Radiology / Imaging

therapeutic_indication:

The system is intended for head and whole body attenuation corrected PET imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images, and to be used by trained healthcare professionals for imaging the distribution of radiopharmaceuticals in the body for assessment of metabolic (molecular) and physiologic functions in patients of all ages. It can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. It can assist in radiotherapy planning and can be used as a stand-alone head and whole body multi-slice CT diagnostic imaging system. The Lung Cancer Screening Option is indicated for using low-dose CT for lung cancer screening, which must be performed within the established inclusion criteria of programs/protocols that have been approved and published by a governmental body or professional medical society.

leaflet_short:

Device System Info:[Device with measuring function], [System or Procedure Pack], Please refer to section-above - "Description of intended use".; Models: Discovery MI Digital Ready - S3200A, Discovery MI Digital Ready - S3200EL, Discovery MI Digital Ready - S3200EX, Discovery MI Digital Ready - S3200ES, Discovery MI Digital Ready - S3200MB, Discovery MI Digital Ready - S9130AH, Respiratory Gating for Scanners - E8819KX

authorization_date:

2017-06-02