ProFound AI

FDA UDI

Icad, Inc.·00858012005960·

MammoScreen

FDA UDI

THERAPIXEL·B885MAML2US0·Radiological computer assisted detection and di...

MammoScreen®

FDA registration

THERAPIXEL·2 products·🇫🇷 France

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

FDA registration

SEE-MODE TECHNOLOGIES PTE LTD·2 products·🇸🇬 Singapore

MammoScreen®

FDA registration

Therapixel Inc.·2 products·🇺🇸 United States

TaiHao Radiological Image processing System

FDA registration

ROC Chinese-European Industrial Research Society·2 products·🇹🇼 Taiwan

Transpara 1.7.2

FDA 510(k)

FDA Class 2 ·Radiology

Lunit INSIGHT MMG

FDA 510(k)

FDA Class 2 ·Radiology

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

FDA 510(k)

FDA Class 2 ·Radiology

ProstatID

FDA 510(k)

FDA Class 2 ·Radiology

Transpara

FDA 510(k)

FDA Class 2 ·Radiology

Saige-Dx

FDA 510(k)

FDA Class 2 ·Radiology

Genius AI Detection 2.0

FDA 510(k)

FDA Class 2 ·Radiology

Lunit INSIGHT DBT

FDA 510(k)

FDA Class 2 ·Radiology

Prostate MR AI (VA10A)

FDA 510(k)

FDA Class 2 ·Radiology

MammoScreen

FDA 510(k)

FDA Class 2 ·Radiology

Lunit INSIGHT DBT v1.1

FDA 510(k)

FDA Class 2 ·Radiology

PowerLook Tomo Detection V2 Software

FDA 510(k)

FDA Class 2 ·Radiology

Transpara

FDA 510(k)

FDA Class 2 ·Radiology

ProFound AI Software V3.0

FDA 510(k)

FDA Class 2 ·Radiology