AVIEW Lung Nodule CAD

FDA 510(k)

FDA Class 2 ·Radiology

M-VU CAD STATION

FDA 510(k)

FDA Class 2 ·Radiology

SIRONA CAD/CAM SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

EMIT-CAD QUINIDINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PMMA CAD/CAM DISC

FDA 510(k)

FDA Class 2 ·Dental

QP-Prostate® CAD

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM

FDA 510(k)

FDA Class 2 ·Dental

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

B-CAD SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Sirona Dental CAD/CAM System

FDA 510(k)

FDA Class 2 ·Dental

EVOLUX CAD/CAM PMMA BLOCKS

FDA 510(k)

FDA Class 2 ·Dental

syngo.CT Lung CAD (Version VD30)

FDA 510(k)

FDA Class 2 ·Radiology

CAD-2000 CARDIAC ASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANCE EMIT CAD DISOPYRAMIDE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology