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

TECHFIT Patient-Specific Maxillofacial System

FDA 510(k)

FDA Class 2 ·Dental

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Portux CAD/CAM Disc

FDA 510(k)

FDA Class 2 ·Dental

PROFESSIONAL MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

FDA 510(k)

FDA Class 2 ·Hematology

DRY TIME

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WET-NO-MORE MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NURTURE III

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology