ORTHOHUB EXTERNAL FIXATOR SOFTWARE

FDA 510(k)

FDA Class 2 ·Orthopedic

CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER

FDA 510(k)

FDA Class 2 ·Hematology

DEEP BLUE

FDA 510(k)

FDA Class 2 ·Dental

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

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

FDA 510(k)

FDA Class 2 ·Cardiovascular

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