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

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Injector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1

FDA 510(k)

FDA Class 2 ·Radiology

SKR 4000

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)

FDA 510(k)

FDA Class 2 ·Radiology

GLUCOCARD W Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Radiology

Airway Mobilescope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Balloon Catheter B5-2C

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Hot Biopsy Forceps FD-231

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Prime SP, TSX-303B/1, v8.4

FDA 510(k)

FDA Class 2 ·Radiology

Xario 100 Diagnostic Ultrasound System, V5.0

FDA 510(k)

FDA Class 2 ·Radiology