XIDF-AWS801, Angio Workstation, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Applanation tonometer AT-2

FDA 510(k)

FDA Class 2 ·Ophthalmic

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

FDA 510(k)

FDA Class 2 ·Radiology

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