Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.3

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020/A9, V5.0

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Alphenix, INFX-8000V/B, V8.0

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package, VSTP-002A V2.0

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Elan 1.5T, MRT-2020, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Orian 1.5T, MRT-1550, V4.5

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Orian 1.5T, MRT-1550, V4.5

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0

FDA 510(k)

FDA Class 2 ·Radiology

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology