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

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

FDA 510(k)

FDA Class 2 ·Radiology

Cartesion Prime (PCD-1000A/3) V10.15

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Cartesion Prime, PCD-1000A, V10.7

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package, VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

FDA 510(k)

FDA Class 2 ·Radiology