Endoscope Reprocessor OER-Elite

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion LB, TSX-201A/3, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

ASAHI Corsair Armet

FDA 510(k)

FDA Class 2 ·Cardiovascular

PreXion3D Excelsior

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Guide Sheath Kit-401, K-402

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

FDA 510(k)

FDA Class 2 ·Radiology

MINAMO blue; MINAMO viola

FDA 510(k)

FDA Class 2 ·Cardiovascular

FUJIFILM Duodenoscope Model

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)

FDA 510(k)

FDA Class 2 ·Radiology

Tokuyama Rebase III

FDA 510(k)

FDA Class 2 ·Dental

KONICA LASER IMAGER, MODEL DRYPRO MODEL 771

FDA 510(k)

FDA Class 2 ·Radiology

3MP COLOR LCD MONITOR, RADIFORCE RX340

FDA 510(k)

FDA Class 2 ·Radiology

Infinix INFX-8000V, V6.40

FDA 510(k)

FDA Class 2 ·Radiology

Kowa SL-19

FDA 510(k)

FDA Class 2 ·Ophthalmic

PANAVIA SA Cement Universal

FDA 510(k)

FDA Class 2 ·Dental

iTFlow

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

FDA 510(k)

FDA Class 2 ·Radiology

Cartesion Prime (PCD-1000A/3) V10.15

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Balloon Dilator V (with knife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology