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

Multi-Modality Tumor Tracking (MMTT) application

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

Hemoglobin F Quantitation

FDA classification

FDA Class 2 ·Hemoglobin F Quantitation

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PARASCRIPT ACCUDETECT 6.1.0

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PARASCRIPT (R) ACCUDETECT (R)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR