ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1

FDA 510(k)

FDA Class 2 ·Radiology

Dyna-Vision Telemonitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stimuplex Onvision System

FDA 510(k)

FDA Class 2 ·Anesthesiology

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

IQon Spectral CT

FDA 510(k)

FDA Class 2 ·Radiology

Spectral CT

FDA 510(k)

FDA Class 2 ·Radiology

Vereos PET/CT

FDA 510(k)

FDA Class 2 ·Radiology

Allura Xper FD series and Allura Xper OR Table series

FDA 510(k)

FDA Class 2 ·Radiology

VERADIUS UNITY

FDA 510(k)

FDA Class 2 ·Radiology

Precise Image

FDA 510(k)

FDA Class 2 ·Radiology

IntelliSpace Portal Platform

FDA 510(k)

FDA Class 2 ·Radiology

Zenition 90

FDA 510(k)

FDA Class 2 ·Radiology

dS FootAnkle Coil 8ch 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

dS Knee Coil 8ch 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

XPERGUIDE

FDA 510(k)

FDA Class 2 ·Radiology

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

FDA classification

FDA Class 2 ·Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Hemoglobin F Quantitation

FDA classification

FDA Class 2 ·Hemoglobin F Quantitation