189 results · 31ms · Sources: EU EUDAMED, US FDA

OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

FDA 510(k)
FDA Class 2 ·Radiology

BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS

FDA 510(k)
FDA Class 2 ·Radiology

BONE MINERAL DENSITOMETER

FDA 510(k)
FDA Class 2 ·Radiology

HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

FDA 510(k)
FDA Class 2 ·Radiology

MyoSure MANUAL Tissue Removal Device

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Aptima SARS-CoV-2 Assay

FDA 510(k)
FDA Class 2 ·Microbiology

Affirm Prone Biopsy System

FDA 510(k)
FDA Class 2 ·Radiology

MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY

FDA 510(k)
FDA Class 2 ·Radiology

Genius AI Detection 2.0 with CC-MLO Correlation

FDA 510(k)
FDA Class 2 ·Radiology

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

IMAGECHECKER CT CAD SOFTWARE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Brevera Biopsy System with Corlumina Imaging Technology

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SELENIA DIMENSIONS (2D) FFDM SYSTEM

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

FDA Pre-Market Approval
FDA Class 2 ·Aptima HCV Quant Dx Assay

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

FDA Pre-Market Approval
FDA Class 2 ·APTIMA HCV Quant Dx Assay

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·LORAD DIGITAL BREAST IMAGER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM