Aorta-CAD

FDA 510(k)

FDA Class 2 ·Radiology

Lung-CAD

FDA 510(k)

FDA Class 2 ·Radiology

ProFuse CAD

FDA 510(k)

FDA Class 2 ·Radiology

Lung-CAD

FDA 510(k)

FDA Class 2 ·Radiology

BU-CAD

FDA 510(k)

FDA Class 2 ·Radiology

OCCLUFAST CAD

FDA 510(k)

FDA Class 2 ·Dental

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD

edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK

FDA 510(k)

FDA Class 2 ·Dental

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

PRODOSE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HALOLITE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

syngo.CT Lung CAD

FDA 510(k)

FDA Class 2 ·Radiology

SYNGO LUNG CAD

FDA 510(k)

FDA Class 2 ·Radiology