Endoscopic Distal Attachment (AF-D series)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL V7.2 CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-50

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX(TM) F-820, 520

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX SE/RAM-1

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-100

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX CA-1000/SYSMEX CA-5000

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX K-4500

FDA 510(k)

FDA Class 2 ·Hematology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M100

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY