XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE Vision, v7.0

FDA 510(k)

FDA Class 2 ·Radiology

PROBEAT-CR

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Cytology Brush BC-205D

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VISERA 4K UHD SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Xario 200 Diagnostic Ultrasound System V5.0

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Injector NM600/610

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROBEAT-CR

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Radiology

Endoscope Reprocessor OER-Elite

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion LB, TSX-201A/3, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Guide Sheath Kit-401, K-402

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

FDA 510(k)

FDA Class 2 ·Radiology

Infinix INFX-8000V, V6.40

FDA 510(k)

FDA Class 2 ·Radiology

Kowa SL-19

FDA 510(k)

FDA Class 2 ·Ophthalmic

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

FDA 510(k)

FDA Class 2 ·Radiology

Cartesion Prime (PCD-1000A/3) V10.15

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Balloon Dilator V (with knife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology