NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)

FDA 510(k)

FDA Class 2 ·Cardiovascular

GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Neodent Instruments Kits

FDA 510(k)

FDA Class 2 ·General Hospital

Neodent Implant System - GM Line

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System-Easy Pack

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System – Custom Abutments

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System - Zirconia Implant System

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System-Helix NGM Compact Surgical Kit Cases

FDA 510(k)

FDA Class 2 ·General Hospital

Neodent Implant System- GM Titanium Base for Bridge

FDA 510(k)

FDA Class 2 ·Dental