Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

KALMATE MODEL 3A

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MODEL EC9-4 TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON CV70 CARDIOVASCULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON X150 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON P50 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON ACUNAV 8F ULTRASOUND CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOURSIGHT VIEWTOOL IMAGE VIEWER

FDA 510(k)

FDA Class 2 ·Radiology

HUMAN TUBAL FLUID

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON SEQUOIA ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology