CRITICAL CARE HOSPITAL BED (ICU/CCU)

FDA 510(k)

FDA Class 2 ·General Hospital

IMAGE1 GI CCU MODEL 22203020-114

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACU-MED RED MISER HEMOTHORAX BLOOD COLL.

FDA 510(k)

FDA Class 2 ·Anesthesiology

Acu-sInQ Complete Endoscope Cleaning Aid System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Metallic Stent Optimization E.4 SW

FDA 510(k)

FDA Class 2 ·Radiology

OPXION Optical Skin Viewer (OPXSV1-01F)

FDA 510(k)

FDA Class 2 ·Radiology

Ilumien Optis, Optis Integrated, Optis Mobile

FDA 510(k)

FDA Class 2 ·Radiology

Starlight Imaging Catheter

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Mobile System

FDA 510(k)

FDA Class 2 ·Radiology

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

FDA 510(k)

FDA Class 2 ·Radiology

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

FDA 510(k)

FDA Class 2 ·Radiology

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography SYstem

FDA 510(k)

FDA Class 2 ·Radiology

ApolloVue S100 Image System

FDA 510(k)

FDA Class 2 ·Radiology

FORESEE (4C) IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

FDA 510(k)

FDA Class 2 ·Radiology