Pantheris

FDA UDI

AVINGER, INC.·00851354004370·The Pantheris System is intended to remove plaq...

Pantheris

FDA UDI

AVINGER, INC.·00851354004387·The Pantheris System is intended to remove plaq...

Tigereye ST

FDA UDI

AVINGER, INC.·00851354004554·The Tigereye ST System is intended to facilitat...

AptiVue™

FDA UDI

LIGHTLAB IMAGING, INC.·05415067030856·Software Upgrade Kit

Ilumien™

FDA UDI

LIGHTLAB IMAGING, INC.·00812059021338·

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