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

PBC Separator with Selux AST System

FDA 510(k)

FDA Class 2 ·Microbiology

PBC Separator with Selux AST System

FDA 510(k)

FDA Class 2 ·Microbiology

Foam Or Gel Chemical Sterilant/High Level Disinfectant

FDA classification

FDA Class 2 ·Foam Or Gel Chemical Sterilant/High Level Disinfectant

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED

FDA 510(k)

FDA Class 2 ·Orthopedic

REPLICA TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP

FDA 510(k)

FDA Class 2 ·Orthopedic