Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A

FDA 510(k)

FDA Class 2 ·Radiology

15-INCH (38 CM) COLOR LCD MONITOR CDL1576A

FDA 510(k)

FDA Class 2 ·Radiology

SION blue PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single Use Retrieval Nitinol Basket V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FILTRYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2.3MP Color LCD Monitor, RadiForce MX242W

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Aspiration Needle NA-U401SX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

FDA 510(k)

FDA Class 2 ·Radiology

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

FDA 510(k)

FDA Class 2 ·Radiology

CROSSLEAD Tracker

FDA 510(k)

FDA Class 2 ·Cardiovascular

RX NC Takeru PTCA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Revolution Ascend

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OSTEOTRANS-OT SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO KOWA NONMYD ALPHA-DIII

FDA 510(k)

FDA Class 2 ·Ophthalmic

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology