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

VENUS CERVICAL SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Power Acute Triple Lumen Hemodialysis Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACE WIRE TENSION CLAMP

FDA 510(k)

FDA Class 2 ·Orthopedic

DEKA ACE Pump System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NICOLET NEUROPORT/ACE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine