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

DR-ID 1200SDK System

FDA 510(k)

FDA Class 2 ·Radiology

3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Radiology

Nihon Kohden Wireless Input Unit WEE-1200

FDA 510(k)

FDA Class 2 ·Neurology

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

FDA 510(k)

FDA Class 2 ·Radiology

CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL

FDA 510(k)

FDA Class 2 ·Dental

DS CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

MEDICAL DISPLAY, MD205MG

FDA 510(k)

FDA Class 2 ·Radiology

Cartesion Prime, PCD-1000A, V10.7

FDA 510(k)

FDA Class 2 ·Radiology

SLIT LAMP SL-2000

FDA 510(k)

FDA Class 2 ·Ophthalmic

INTERMITTENT INJECTION SITE

FDA 510(k)

FDA Class 2 ·General Hospital

EW10-EC02 Endoscopy Support Program

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEARTRAIL III GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

JMS LCC INSULIN SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

COLOR LCD MONITOR, MODEL RADIFORCE R12

FDA 510(k)

FDA Class 2 ·Radiology