Lung AI (LAI001)

FDA 510(k)

FDA Class 2 ·Radiology

DTX Studio™ Clinic

FDA UDI

Nobel Biocare AB·07332747200584·DTX Studio Clinic 3.4 for Win 64-bit

DTX Studio™ Clinic

FDA UDI

Nobel Biocare AB·07332747200577·DTX Studio Clinic 3.4 for Mac

DTX Studio™ Clinic

FDA UDI

Nobel Biocare AB·07332747199789·DTX Studio Clinic 3.3 for Win 64-bit

DTX Studio™ Clinic

FDA UDI

Nobel Biocare AB·07332747202854·DTX Studio Clinic 4.2 for Mac

DTX Studio™ Clinic

FDA UDI

Nobel Biocare AB·07332747202830·DTX Studio Clinic 4.2 for Win 64-bit

DTX Studio™ Clinic

FDA UDI

Nobel Biocare AB·07332747199772·DTX Studio Clinic 3.3 for Mac

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·CLEARREAD DETECT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·THE IMAGECHECKER SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M1000 IMAGECHECKER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM