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

Vassallo GT 018 Hybrid

FDA 510(k)

FDA Class 2 ·Cardiovascular

AeroDR SYSTEM 2

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Ultrasound System SONIMAGE HS1

FDA 510(k)

FDA Class 2 ·Radiology

Honda Walking Assist Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

Ultrasound System SONIMAGE MX1

FDA 510(k)

FDA Class 2 ·Radiology

Rhino-Laryngo Videoscope Olympus ENF-VT3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADAMS A1c HA-8180V, CALIBRATOR 80

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MHI-TM2000 Linear Accelerator System, VERO, Imavis

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VASSALLO GT Crossing14

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

D function

FDA 510(k)

FDA Class 2 ·Physical Medicine