E3 and Profile

FDA 510(k)

FDA Class 2 ·Neurology

ViewPoint 6

FDA 510(k)

FDA Class 2 ·Radiology

Versana Premier

FDA 510(k)

FDA Class 2 ·Radiology

Vivid E80/ Vivid E90/ Vivid E95

FDA 510(k)

FDA Class 2 ·Radiology

Vscan Air

FDA 510(k)

FDA Class 2 ·Radiology

ViewPoint 6

FDA 510(k)

FDA Class 2 ·Radiology

Vivid iq

FDA 510(k)

FDA Class 2 ·Radiology

Vivid E80, Vivid E90, Vivid E95

FDA 510(k)

FDA Class 2 ·Radiology

Vivid E80, Vivid E90, Vivid E95

FDA 510(k)

FDA Class 2 ·Radiology

Venue

FDA 510(k)

FDA Class 2 ·Radiology

HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

FDA 510(k)

FDA Class 2 ·Hematology

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System

FDA 510(k)

FDA Class 2 ·Microbiology

VirtuOst Vertebral Fracture Assessment

FDA 510(k)

FDA Class 2 ·Radiology

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel 2 plus (RP2plus)

FDA 510(k)

FDA Class 2 ·Pathology

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BPCARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

FDA 510(k)

FDA Class 2 ·Microbiology