Eu Mdr Eu Md Class 2b On The Market 🇺🇸 United States

Discovery IQ

GE Medical Systems, LLC · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
0
Countries
12
Notified Bodies
0

Let the assistant research this device

The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.

Free to try · every answer cites its records

Basic Information

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

Additional Description

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

CND Nomenclature Codes

Code Description
Z11020301 CT/PET SYSTEMS

Available In Countries

🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇫🇷 France 🇮🇹 Italy 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇹🇷 Türkiye

Similar Devices

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

View all