Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Hot Biopsy Forceps FD-231

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Prime SP, TSX-303B/1, v8.4

FDA 510(k)

FDA Class 2 ·Radiology

Xario 100 Diagnostic Ultrasound System, V5.0

FDA 510(k)

FDA Class 2 ·Radiology

21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)

FDA 510(k)

FDA Class 2 ·Radiology

Alphenix, INFX-8000C/B, V8.0

FDA 510(k)

FDA Class 2 ·Radiology

MR Elastography; MZEK-001A

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

FDA 510(k)

FDA Class 2 ·Radiology

Water Container (MAJ-901); Water Container (MAJ-902)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Viamo c100 TUS-VC100 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1

FDA 510(k)

FDA Class 2 ·Radiology

24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFX-8000C, V6.20

FDA 510(k)

FDA Class 2 ·Radiology