Discovery IQ

Primary DI

00840682125703

Basic UDI-DI Code

8406821BUG00414HB

Reference

PCM-PET0008A

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

GE Medical Systems, LLC

GE Discovery IQ PET/CT system is intended for head and whole-body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The system is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions in patients of all ages. This 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. This device can also assist in radiotherapy planning. The system can also be used as a stand-alone head and whole-body multi-slice computed tomography (CT) diagnostic imaging systems

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).