12 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Turner Imaging Systems, Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.
Lunit Inc.
Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·5 Devices·3 Importers
Lunit INSIGHT DBT
Device
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·On the market·27 countries
Lunit INSIGHT DBT
Device
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·On the market·20 countries
Lunit INSIGHT CXR
Device
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·On the market·20 countries
Lunit INSIGHT CXR
Device
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·On the market·30 countries
Lunit INSIGHT MMG
Device
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·On the market·30 countries
Smart-C
Device
EU MDD
·
Eu Md Class 2b
·Turner Imaging Systems, Inc.·On the market·2 countries
CE 735600
Certificate
MDD Annex II (excluding section 4)·Turner Imaging Systems, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
Smart-C Imaging System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Turner Imaging Systems, Inc.·1 device
Lunit INSIGHT CXR
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·2 devices
Lunit INSIGHT MMG
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·3 devices