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

FDA 510(k)

FDA Class 2 ·Radiology

MINAMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package, VSTP-002A V2.0

FDA 510(k)

FDA Class 2 ·Radiology

DIGITAL PRINTER P6000D SERIES, MODEL P6000DU

FDA 510(k)

FDA Class 2 ·Radiology

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM

FDA 510(k)

FDA Class 2 ·Radiology

Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Anzai Respiratory Gating System

FDA 510(k)

FDA Class 2 ·Radiology

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

K-SHIELD Zen

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)

FDA 510(k)

FDA Class 2 ·Radiology

Y-MIC

FDA 510(k)

FDA Class 2 ·Dental

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

Aquilion Lightning, TSX-035A/4 and /5, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA

FDA 510(k)

FDA Class 2 ·Cardiovascular

CSX-30 Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology