Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

FDA 510(k)

FDA Class 2 ·Radiology

Cartesion Prime, PCD-1000A, V10.7

FDA 510(k)

FDA Class 2 ·Radiology

Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

Visera Elite II Video System Center, Visera Elite II Endoeye 3D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways

FDA 510(k)

FDA Class 2 ·Radiology

High Flow Insufflation Unit (UHI-4)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

True Enhance DL

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Rhino-Laryngo Fiberscope Olympus ENF-GP2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Single Use Aspiration Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS

FDA 510(k)

FDA Class 2 ·Radiology

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