19 results · 30ms · Sources: EU EUDAMED, US FDA

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval
FDA Class 3 ·PROGENSA PCA3 ASSAY

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOGRAPHE PRISTINA 3D

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS - Automated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS (Automated Breast Ultrasound System) 2.0

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS Autoated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS 2.0 Automated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Senographe Pristina 3D

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Senographe Pristina 3D and SenoClaire