Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5

FDA 510(k)

FDA Class 2 ·Radiology

VASSALLO GT EXT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single Use Electrosurgical knife

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XIDF-AWS801, Angio Workstation, V6.20

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ultrasound System SONIMAGE MX1

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Hot Biopsy Forceps FD-231

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion ONE (TSX-306A/3) V10.0

FDA 510(k)

FDA Class 2 ·Radiology

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Galan 3T, MRT-3020, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Distal Attachment D-201 Series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

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

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