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

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6

FDA 510(k)

FDA Class 2 ·Radiology

ILUMIEN OPTIS

FDA 510(k)

FDA Class 2 ·Radiology

NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER

FDA 510(k)

FDA Class 2 ·Radiology