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

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Ultimax-i, DREX-UI80 (V1.60)

FDA 510(k)

FDA Class 2 ·Radiology

Low Dose Lung Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

Cartesion Prime

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package, VSTP-002A

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-308A/3) V1.5

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Alphenix, INFX-8000V/B, /S, V9.1

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Orian 1.5T, MRT-1550, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

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 a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020/A7, V5.0

FDA 510(k)

FDA Class 2 ·Radiology