Optima CT660s

FDA registration

GE Healthcare (China) Co., Ltd.·1 product·🇨🇳 China

GE OPTIMA 660 128-SLICE CT

FDA registration

EvERX PTY LTD·1 product·🇦🇺 Australia

Zimmer Patient Specific Instruments Planner

FDA registration

Materialise Sdn Bhd·4 products·🇲🇾 Malaysia

GE Optima 660 CT

FDA registration

CIS COMPUTERISED IMAGING SERVICES PTY LTD·1 product·🇦🇺 Australia

Optima CT660s

FDA registration

GE MEDICAL SYSTEMS, LLC·1 product·🇺🇸 United States

Trinity Medical Devices

FDA registration

TRINITY MEDICAL DEVICES INC.·1 product·🇺🇸 United States

EliA™ MPOS Immunoassay

FDA registration

PHADIA US INC.·3 products·🇺🇸 United States

EliA™ MPOS Immunoassay

FDA registration

PHADIA AB·3 products·🇸🇪 Sweden

EUROLINE ENA Profile 9 Ag (IgG)

FDA registration

EUROIMMUN Medizinische Labordiagnostika AG·5 products·🇩🇪 Germany

EliA™ MPOS Immunoassay

FDA registration

PHADIA AB·3 products·🇸🇪 Sweden

SAS FLUALERT A&B, SAS INFLUENZA A TEST

FDA 510(k)

FDA Class 2 ·Microbiology

QLAB QUANTIFICATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

Devices Detecting Influenza A, B, And C Virus Antigens

FDA classification

FDA Class 2 ·Devices Detecting Influenza A, B, And C Virus Antigens

System, Image Processing, Radiological

FDA classification

FDA Class 2 ·System, Image Processing, Radiological