ProFound AI Software V2.1

FDA 510(k)

FDA Class 2 ·Radiology

Saige-Dx (3.1.0)

FDA 510(k)

FDA Class 2 ·Radiology

BU-CAD

FDA 510(k)

FDA Class 2 ·Radiology

MammoScreen 2.0

FDA 510(k)

FDA Class 2 ·Radiology

Genius AI Detection 2.0 with CC-MLO Correlation

FDA 510(k)

FDA Class 2 ·Radiology

QP-Prostate® CAD

FDA 510(k)

FDA Class 2 ·Radiology

Saige-Dx

FDA 510(k)

FDA Class 2 ·Radiology

Transpara (2.1.0)

FDA 510(k)

FDA Class 2 ·Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

PDQ AND PDQ-TI ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

PDQ AMEBIASIS

FDA 510(k)

FDA Class 2 ·Microbiology

Extension Set with BD Q-Syte Luer Access Split Septum

FDA 510(k)

FDA Class 2 ·General Hospital

BODYSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENTURI MiNO TG600/14

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BODYSTAY

FDA 510(k)

FDA Class 2 ·Cardiovascular

BODYSTAT DUALSCAN 2005

FDA 510(k)

FDA Class 2 ·Cardiovascular

BODYSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular