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

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Envision Mammography Platform

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

Automated Breast Ultrasound

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

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-SPHERES

Automated Breast Ultrasound

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

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·TheraSphere™

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval
FDA Class 3 ·CLINI-THERM MARK I/IV

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VH8500 HYPERTHERMIA TREATMENT SYSTEM

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Automated Breast Ultrasound

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

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval
FDA Class 3 ·CLINI-THERM MARK I/IV

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·KONING BREAST CT (MODEL CBCT 1000)

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Contrast Media, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VH8500 HYPERTHERMIA TREATMENT SYSTEM