KOWA KT-800

FDA 510(k)

FDA Class 2 ·Ophthalmic

21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB

FDA 510(k)

FDA Class 2 ·Radiology

Disposal Lens Cleaning Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECHELON Oval V6.2 MRI System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless

FDA 510(k)

FDA Class 2 ·Radiology

DIRECT DIGITIZER REGIUS MODEL 370

FDA 510(k)

FDA Class 2 ·Radiology

HAL for Medical Use(Lower Limb type)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PRESS DUO elite, PRESS DUO elite AG

FDA 510(k)

FDA Class 2 ·Cardiovascular

20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB

FDA 510(k)

FDA Class 2 ·Radiology

Digital Radiography CXDI-Elite, Digital Radiography E1

FDA 510(k)

FDA Class 2 ·Radiology

Digital Radiography CXDI-Pro, Digital Radiography D1

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve SP (TSX-307B/1) V1.3

FDA 510(k)

FDA Class 2 ·Radiology

VASSALLO GT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRP-LATEX (II)X2 SEIKEN ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Mini Ridge Filter and auxiliary functions for PROBEAT-V

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

MOBILE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ReBOSSIS85

FDA 510(k)

FDA Class 2 ·Orthopedic

Ultimax-i, DREX-UI80 (V1.60)

FDA 510(k)

FDA Class 2 ·Radiology