Vantage Titan 1.5T, MRT-1510, M-Power GX

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Surgic Pro, Surgic Pro+

FDA 510(k)

FDA Class 1 ·Dental

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