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

Pump, Infusion, Pca

FDA classification

FDA Class 2 ·Pump, Infusion, Pca

Droplet Digital Pcr System

FDA classification

FDA Class 2 ·Droplet Digital Pcr System

Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Endoscopic Magnetic Retriever, Exempt

FDA classification

FDA Class 2 ·Endoscopic Magnetic Retriever, Exempt

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Test, Factor V Leiden Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor V Leiden Mutations, Genomic Dna Pcr

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

FDA classification

FDA Class 2 ·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set