189 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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