Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

SepaSperm Washing Solution, SepaSperm Solution

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

FDA 510(k)

FDA Class 2 ·General Hospital

Ultimax-i

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Elan 1.5T, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Radiology

ROKI Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Small Field Applicator

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package, VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Titan 1.5T, MRT-1510, V3.6 Software

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Aspiration Needle NA-U401SX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Olympus Small Intestinal Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology