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

FDA 510(k)

FDA Class 2 ·Radiology

EVIS EXERA III Bronchovideoscope Olympus BF-XT190

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Xario 200 Diagnostic Ultrasound System V6.0

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Thunderbeat Open Fine Jaw Type X Hand Instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Konicaminolta DI-X1

FDA 510(k)

FDA Class 2 ·Radiology

Mammography Color Display DP-M3010

FDA 510(k)

FDA Class 2 ·Radiology

Celesteion, PCA-9000A/3

FDA 510(k)

FDA Class 2 ·Radiology

Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Cytology Brush BC-202D/203D Series

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Aplio 500/400/300 Diagnostic Ultrasound System V6.0

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 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