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

Visera Elite II Video System Center

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Aspiration Needle NA-U200H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCENARIA View

FDA 510(k)

FDA Class 2 ·Radiology

THUNDERBEAT Open Fine Jaw

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Ultrasound System SONIMAGE HS1

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Balloon Dilator V (with Knife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vantage Galan 3T, V4.6

FDA 510(k)

FDA Class 2 ·Radiology