Ellipsys Vascular Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Transpara 1.7.0

FDA 510(k)

FDA Class 2 ·Radiology

Transpara

FDA 510(k)

FDA Class 2 ·Radiology

MammoScreen® (3)

FDA 510(k)

FDA Class 2 ·Radiology

MammoScreen® (4)

FDA 510(k)

FDA Class 2 ·Radiology

Genius AI Detection

FDA 510(k)

FDA Class 2 ·Radiology

ProFound AI Software V2.1

FDA 510(k)

FDA Class 2 ·Radiology

WavelinQ Plus EndoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

everlinQ endoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411

eQUANT System

FDA 510(k)

FDA Class 2 ·Microbiology