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

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning (TSX-035A/2, V7.0)

FDA 510(k)

FDA Class 2 ·Radiology

OLYMPUS URF-P6/P6R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Vantage Galan 3T, MRT-3020/A9, V5.0

FDA 510(k)

FDA Class 2 ·Radiology

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ultrasound System SONIMAGE HS1

FDA 510(k)

FDA Class 2 ·Radiology

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

FDA 510(k)

FDA Class 2 ·General Hospital

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RICOH MEG

FDA 510(k)

FDA Class 2 ·Neurology

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Infinix-i, INFX-8000V, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle

FDA 510(k)

FDA Class 2 ·Anesthesiology

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)

FDA 510(k)

FDA Class 2 ·Radiology

4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

FDA 510(k)

FDA Class 2 ·Radiology