DUAL SHOT - CONTRAST DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AE-120A EEG Head Set

FDA 510(k)

FDA Class 2 ·Neurology

MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)

FDA 510(k)

FDA Class 1 ·Dental

MRSA-SCREEN

FDA 510(k)

FDA Class 2 ·Microbiology

RADspeed Pro

FDA 510(k)

FDA Class 2 ·Radiology

CATARACTSCREENER CT - S

FDA 510(k)

FDA Class 2 ·Ophthalmic

SDL-10 DIAGNOSTIC ULTRASOUND

FDA 510(k)

FLAT PANEL DISPLAYS, CDL SERIES

FDA 510(k)

FDA Class 2 ·Radiology

Nihon Kohden Afib Detection Program QP-039P

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROBEAT-CR

FDA 510(k)

FDA Class 2 ·Radiology

PreXion3D Expedition

FDA 510(k)

FDA Class 2 ·Radiology

OTW Takeru PTCA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Radiology

Aperta NSE PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

SK S-RAY GRIDS

FDA 510(k)

FDA Class 1 ·Radiology

ASAHI Corsair Armet

FDA 510(k)

FDA Class 2 ·Cardiovascular

PreXion3D Excelsior

FDA 510(k)

FDA Class 2 ·Radiology