IMALUX NIRIS IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SpectraWAVE Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

IMALUX OCT IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES

FDA 510(k)

FDA Class 2 ·Radiology

OPUSWAVE Dual Sensor Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

VIVOSIGHT TOPICAL OCT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER

FDA 510(k)

FDA Class 2 ·Radiology

HyperVue™ Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Perimeter Otis™ 1.0 Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

deepLive

FDA 510(k)

FDA Class 2 ·Radiology

NvisionVLE Low-profile Optical Probe

FDA 510(k)

FDA Class 2 ·Radiology

LuminScan (TM) Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Integrated System Mobile Workstation

FDA 510(k)

FDA Class 2 ·Radiology

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

FDA 510(k)

FDA Class 2 ·Radiology

SKINTELL

FDA 510(k)

FDA Class 2 ·Radiology

C7 XR IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Sterile bone screw (PEEK ACL screw)

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES

FDA 510(k)

FDA Class 2 ·Orthopedic

ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)

FDA 510(k)

FDA Class 2 ·Hematology