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

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning, TSX-036A/1, V8.4

FDA 510(k)

FDA Class 2 ·Radiology

Applanation tonometer AT-1

FDA 510(k)

FDA Class 2 ·Ophthalmic

Cartesion Prime

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package, VSTP-002A

FDA 510(k)

FDA Class 2 ·Radiology

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BODY SIGNAL ECG ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

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 Titan 3T, MRT-3010/A7, M-Power GX

FDA 510(k)

FDA Class 2 ·Radiology

SIGNA Pioneer

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

Olympus Small Intestinal Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Radiology

ENDOSCOPE REPROCESSOR OER-Elite

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECHELON Synergy MRI System

FDA 510(k)

FDA Class 2 ·Radiology

PROBEAT-FR

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