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

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

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

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

XIDF-AWS801, Angio Workstation, V6.10

FDA 510(k)

FDA Class 2 ·Radiology

SB Knife Jr2 (MD-47702 and MD-47702L)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Aspiration Needle NA-U200H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)

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

Vantage Orian 1.5T, MRT-1550, V4.5

FDA 510(k)

FDA Class 2 ·Radiology

MHI-TM2000 LINEAR ACCELERATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

ULTRASOUND SYSTEM SONIMAGE HS 1

FDA 510(k)

FDA Class 2 ·Radiology